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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05876754
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05876754
Ethics application status
Date submitted
17/05/2023
Date registered
25/05/2023
Date last updated
5/03/2024
Titles & IDs
Public title
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
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Scientific title
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
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Secondary ID [1]
0
0
2022-501463-40
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Secondary ID [2]
0
0
DIM-95031-002
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Universal Trial Number (UTN)
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Trial acronym
ProvIDHe
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ivosidenib Oral Tablet
Experimental: Ivosidenib - Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles
Treatment: Drugs: Ivosidenib Oral Tablet
Ivosidenib 500 mg
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Adverse Events (AEs) from Day 1 of Cycle 1 through 28 days after last study treatment
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Assessment method [1]
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AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. All reported AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), using the latest version.
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Timepoint [1]
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Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
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Primary outcome [2]
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Number of Serious Adverse Events (SAEs) during the study treatment period (from Day 1 of Cycle 1 through the last study treatment intake or withdrawal of consent, whichever comes first).
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Assessment method [2]
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SAEs related to study drug will be collected irrespective of the time of onset. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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Timepoint [2]
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Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment, 6 months after last study treatment, 12 months after last study treatment, 18 months after last study treatment
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Primary outcome [3]
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0
Number of QT prolongation events during electrocardiogram (ECG) assessed as Grade 2 or worse occurring from Day 1 of Cycle 1 through 28 days after last study treatment
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Assessment method [3]
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QT interval, using Fridericia's formula [QTcF], to average QTc interval > 480 to 500msec (Grade 2) or worse, as seen during an ECG. This is classified as an Adverse Event of Special Interest (AESI) for this study.
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Timepoint [3]
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Day 1 of cycle 1, week 2 of cycle 1, week 3 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
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Primary outcome [4]
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Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
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Assessment method [4]
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ECOG PS scoring consists of Grade 0 - 5, with 0 being the patient is fully active and 5 being the patient is dead. Descriptive statistics of ECOG PS over time will be summarized by frequency. Shift tables may be provided for ECOG PS from baseline to worst value of post-baseline assessments.
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Timepoint [4]
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Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
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Primary outcome [5]
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Number of Adverse Events (AEs) leading to discontinuation or death from day 1 through 28 days after the last study treatment
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Assessment method [5]
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Total number of AEs that result in discontinuation from treatment or death. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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Timepoint [5]
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Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
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Primary outcome [6]
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Total laboratory abnormalities using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grading scale or the low/normal/high classifications based on laboratory normal ranges.
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Assessment method [6]
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Listing of all laboratory hematology, coagulation, and chemistry data with values flagged as abnormal to show the corresponding NCI-CTCAE grades and the classifications relative to the laboratory normal ranges.
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Timepoint [6]
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Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
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Primary outcome [7]
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Change from baseline to the worst on-treatment value of laboratory abnormalities.
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Assessment method [7]
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Abnormalities will be classified by using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grading scale or the low/normal/high classifications based on laboratory normal ranges. Shift tables using NCI-CTCAE grades to compare baseline to the worst on-treatment value will be used. For laboratory tests, including hematology, coagulation, and chemistry, where NCI-CTCAE grades are not defined, shift tables using the low/normal/high [low and high] classification to compare baseline to the worst on treatment may be generated. On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose.
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Timepoint [7]
0
0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
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Primary outcome [8]
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Number of patients with vital sign values outside limits of the normal range at each time point.
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Assessment method [8]
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Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
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Timepoint [8]
0
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Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
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Primary outcome [9]
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Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
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Assessment method [9]
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On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose. Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
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Timepoint [9]
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Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
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Secondary outcome [1]
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Progression-free survival (PFS) time beginning at enrollement
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Assessment method [1]
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PFS is defined as the time from the date of enrollment to the date at which the disease escalates or progresses. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
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Timepoint [1]
0
0
through 28 days after last treatment
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Secondary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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OS is defined as the time from date of enrollment to the date of death due to any cause. It will be assessed using the Kaplan-Meier (KM) method curves and estimates.
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Timepoint [2]
0
0
through 28 days after last treatment
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Secondary outcome [3]
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Duration of response (DOR)
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Assessment method [3]
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DOR is defined as the time from the date of response to either progression or death. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
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Timepoint [3]
0
0
through 28 days after last treatment
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Secondary outcome [4]
0
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Time to response (TTR)
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Assessment method [4]
0
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TTR is defined as the time from the date of enrollment to the date of response. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
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Timepoint [4]
0
0
through 28 days after last treatment
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Secondary outcome [5]
0
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Change from baseline of Quality of life scores
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Assessment method [5]
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Measured by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21). EORTC QLQ-BIL21, will be evaluated for patients with a baseline assessment and at least 1 post-baseline QLQ-BIL21 assessment that generates a score. Change from baseline for each time point, will be summarized using descriptive statistics.
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Timepoint [5]
0
0
through 28 days after last study treatment
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Secondary outcome [6]
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Proportion of days at home or hospital for all patients
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Assessment method [6]
0
0
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Timepoint [6]
0
0
through 28 days after last treatment
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Secondary outcome [7]
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Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
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Assessment method [7]
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Health economic measures, as assessed by the EQ-5D-5L, will be evaluated for patients with a baseline assessment and at least 1 post-baseline EQ-5D-5L assessment that generate a score. Change from baseline scores for each time point will be quantified with descriptive statistics.
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Timepoint [7]
0
0
through 28 days after last treatment
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Eligibility
Key inclusion criteria
- Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for
curative-intent resection, transplantation, or ablative therapies
- Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
- Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from
any side effects
- Female patients of childbearing potential must have a negative blood pregnancy test
prior to starting treatment and must agree to use 2 forms of contraception from the
time they enroll to 1 month after their last dose of study drug
- Male patients with a female partner with childbearing potential must also agree to use
2 forms of contraception from the time they enroll to 1 month after their last dose of
study drug
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Received a prior IDH1 inhibitor
- Have received a transplant
- Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1
of Cycle 1
- Have received hepatic radiation, chemoembolization, and radiofrequency ablation within
4 weeks prior to Day 1 of Cycle 1
- Have ongoing brain metastases requiring steroids
- Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1
- Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human
immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome
(AIDS) related illness
- Are pregnant or breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal brisbane & Women's Hospital - Brisbane
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Recruitment hospital [2]
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St Vincent's Hospital - Fitzroy
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Recruitment hospital [3]
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St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) - Subiaco
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Recruitment hospital [4]
0
0
Kinghorn Cancer Centre - Sydney
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Recruitment hospital [5]
0
0
The Queen Elizabeth Hospital - Woodville
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Recruitment postcode(s) [1]
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0
- Brisbane
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Recruitment postcode(s) [2]
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- Fitzroy
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Recruitment postcode(s) [3]
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0
- Subiaco
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Recruitment postcode(s) [4]
0
0
- Sydney
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Recruitment postcode(s) [5]
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0
- Woodville
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Recruitment outside Australia
Country [1]
0
0
Austria
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State/province [1]
0
0
Graz
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Country [2]
0
0
Austria
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State/province [2]
0
0
Linz
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Country [3]
0
0
Austria
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State/province [3]
0
0
Salzburg
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Country [4]
0
0
Austria
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State/province [4]
0
0
Wien
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Brussel
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Gent
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Leuven
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Woluwe-Saint-Lambert
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Country [9]
0
0
France
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State/province [9]
0
0
Lyon
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Country [10]
0
0
France
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State/province [10]
0
0
Marseille
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Country [11]
0
0
France
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State/province [11]
0
0
Montpellier
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Country [12]
0
0
France
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State/province [12]
0
0
Nantes
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Country [13]
0
0
France
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State/province [13]
0
0
Paris
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Country [14]
0
0
France
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State/province [14]
0
0
Pessac
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Country [15]
0
0
France
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State/province [15]
0
0
Poitiers
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Country [16]
0
0
Germany
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State/province [16]
0
0
Berlin
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Country [17]
0
0
Germany
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State/province [17]
0
0
Dresden
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Country [18]
0
0
Germany
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State/province [18]
0
0
Düsseldorf
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Country [19]
0
0
Germany
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State/province [19]
0
0
Frankfurt
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Country [20]
0
0
Germany
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State/province [20]
0
0
Freiburg
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Country [21]
0
0
Germany
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State/province [21]
0
0
Hannover
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Country [22]
0
0
Germany
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State/province [22]
0
0
München
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Country [23]
0
0
Italy
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State/province [23]
0
0
Bologna
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Country [24]
0
0
Italy
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State/province [24]
0
0
Florence
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Country [25]
0
0
Italy
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State/province [25]
0
0
Milano
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Country [26]
0
0
Italy
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State/province [26]
0
0
Napoli
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Country [27]
0
0
Italy
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State/province [27]
0
0
Reggio Emilia
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Country [28]
0
0
Italy
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State/province [28]
0
0
Roma
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Country [29]
0
0
Italy
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State/province [29]
0
0
Rozzano
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Country [30]
0
0
Italy
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State/province [30]
0
0
San Giovanni Rotondo
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Country [31]
0
0
Italy
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State/province [31]
0
0
Turin
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Country [32]
0
0
Italy
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State/province [32]
0
0
Verona
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Country [33]
0
0
Netherlands
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State/province [33]
0
0
Amsterdam
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Country [34]
0
0
Netherlands
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State/province [34]
0
0
Limburg
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Country [35]
0
0
Spain
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State/province [35]
0
0
A Coruña
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Country [36]
0
0
Spain
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State/province [36]
0
0
Barcelona
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Country [37]
0
0
Spain
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State/province [37]
0
0
Córdoba
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Country [38]
0
0
Spain
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State/province [38]
0
0
Elche
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Country [39]
0
0
Spain
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State/province [39]
0
0
Madrid
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Country [40]
0
0
Spain
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State/province [40]
0
0
Pamplona
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Country [41]
0
0
Spain
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State/province [41]
0
0
Santander
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Country [42]
0
0
Sweden
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State/province [42]
0
0
Gothenburg
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Country [43]
0
0
Sweden
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State/province [43]
0
0
Stockholm
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Country [44]
0
0
United Kingdom
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State/province [44]
0
0
Birmingham
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Country [45]
0
0
United Kingdom
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State/province [45]
0
0
Glasgow
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Country [46]
0
0
United Kingdom
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State/province [46]
0
0
London
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Country [47]
0
0
United Kingdom
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State/province [47]
0
0
Manchester
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Country [48]
0
0
United Kingdom
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State/province [48]
0
0
Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Servier Affaires Médicales
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05876754
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Institut de Recherches Internationales Servier, Clinical Studies Department
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Address
0
0
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Country
0
0
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Phone
0
0
+33 1 55 72 60 00
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05876754
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1]
143
The Queen Elizabeth Hospital
Recruitment hospital [2]
144
St Vincent's Hospital (Melbourne) Ltd
Recruitment postcode(s) [1]
144
5011
Recruitment postcode(s) [2]
145
3065
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
Approved
Public notes
Contacts
Principal investigator
Title
393
0
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Name
393
0
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Address
393
0
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Country
393
0
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Phone
393
0
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Fax
393
0
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Email
393
0
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Contact person for public queries
Title
394
0
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Name
394
0
Servier Pharmaceuticals
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Address
394
0
L4, Building 9, 588A Swan Street Burnley, VIC 3121, Australia
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Country
394
0
Australia
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Phone
394
0
1800 153 590
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Fax
394
0
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Email
394
0
[email protected]
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Contact person for scientific queries
Title
395
0
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Name
395
0
Servier Pharmaceuticals
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Address
395
0
L4, Building 9, 588A Swan Street Burnley, VIC 3121, Australia
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Country
395
0
Australia
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Phone
395
0
1800 153 590
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Fax
395
0
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Email
395
0
[email protected]
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Download to PDF