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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03690154




Registration number
NCT03690154
Ethics application status
Date submitted
21/09/2018
Date registered
1/10/2018

Titles & IDs
Public title
A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML
Scientific title
A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)
Secondary ID [1] 0 0
FN-1501-UP1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Solid Tumors 0 0
Acute Myeloid Leukemia Refractory 0 0
Acute Myeloid Leukemia, in Relapse 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FN-1501

Experimental: FN-1501 -


Treatment: Drugs: FN-1501
Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Timepoint [1] 0 0
From first dose until 30 days after the last dose.
Primary outcome [2] 0 0
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Timepoint [2] 0 0
During the first year.
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last)
Timepoint [1] 0 0
During the first year.
Secondary outcome [2] 0 0
Area under concentration-time curve from 0 to 24 hours (AUC(0-24))
Timepoint [2] 0 0
During the first year.
Secondary outcome [3] 0 0
Area under the plasma concentration time curve from zero to infinity (AUC0-8)
Timepoint [3] 0 0
During the first year.
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [4] 0 0
During the first year.
Secondary outcome [5] 0 0
Time to maximum observed plasma concentration (tmax)
Timepoint [5] 0 0
During the first year.
Secondary outcome [6] 0 0
Terminal half-life (t1/2)
Timepoint [6] 0 0
During the first year.
Secondary outcome [7] 0 0
Clearance (CL)
Timepoint [7] 0 0
During the first year.
Secondary outcome [8] 0 0
Apparent volume of distribution (Vd)
Timepoint [8] 0 0
During the first year.
Secondary outcome [9] 0 0
Measurement of anti-tumor activity of FN-1501 according to RECIST version 1.1 (solid tumor)
Timepoint [9] 0 0
During the first year.
Secondary outcome [10] 0 0
Measurement of anti-tumor activity of FN-1501 including but not limited to CT/MRI images
Timepoint [10] 0 0
During the first year.

Eligibility
Key inclusion criteria
* Male and female 18 years old and above
* Able to understand and sign informed consent form
* Patients with histologically or cytologically confirmed advanced solid tumors who have relapsed or refractory disease or relapsed/refractory AML for which no standard therapies expected to produce clinical benefit to the patient are available
* Patients with diagnosed solid tumors must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
* Patients with relapsed or refractory AML must be diagnosed with AML based on World Health Organization (WHO) criteria (= 20% blasts in bone marrow). Patients with acute promyelocytic leukemia are excluded
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Have discontinued all previous cancer therapies for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute adverse effects of therapy
* Expected to survive at least 2 to 3 months
* LVEF = 50% and QTc interval < 450 ms
* Women shall meet either of the following conditions before enrollment
* Infertile, defined as having a bilateral oophorectomy (ovariectomy), or a bilateral tubal ligation, or being post-menopausal for at least 1 year.
* For those of childbearing potential, they should have a negative serum pregnancy test during screening, agree to refrain from lactation, and use effective contraception such as hormonal methods associated with inhibition of ovulation, condom, intra-uterine device, surgical sterilization (including partner's vasectomy) or sexual abstinence during the study and 30 days after the last administration of study drug.
* Men who are engaging or plan to engage in sexual activity with a female of childbearing potential must either have a prior vasectomy or agree to use effective contraception such as condoms, sexual abstinence and appropriate methods taken by their partner(s) during the study and 90 days after the last dose.
* Patients must have adequate organ functions as indicated by the following screening laboratory values:
* Serum total bilirubin = 1.5 × upper limit normal (ULN) (Serum total bilirubin can be = 3.0 × ULN if patients have hemolysis or congenital hemolytic diseases)
* Creatinine < 1.5 × ULN or estimated creatinine clearance = 50 mL/min
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN or

* 5 X ULN for patient with liver metastases
* Absolute neutrophil count (ANC) = 1.5×10^9/L
* Platelets = 100×10^9/L
* Hemoglobin = 9 g/dL or = 5.6 mmol/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample) Note: Laboratory requirements for complete blood counts (hemoglobin, ANC, and platelets) do not apply to AML patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participation in another therapeutic clinical trial within 3 weeks of enrollment
* A previous toxicity-related reaction towards cancer therapy have not recovered within 2 weeks of enrollment (>Grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03)
* Having received a major surgical operation within 4 weeks of enrollment or not yet completely recovered from a previous operation
* Any serious or uncontrollable systemic disease, including but not limited to: Hypertension (after treatment, systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg) and active hemorrhagic disorders; patients who are determined by investigators as otherwise not suitable for participation in this study.Note: Patients that in the judgment of the investigator have clinical signs of disease progression during the screening period (i.e.: febrile neutropenia, ascites requiring drainage, hospitalization due to worsening underlying disease, etc.) will not be eligible for participation.
* Active known infection, including hepatitis B, hepatitis C, and human immunodeficiency virus
* Primary central nervous system (CNS) tumor or CNS metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with a history of CNS metastases or cord compression are allowable if they have been definitively treated and have been clinically stable for at least 3 months, and off steroids or anticonvulsants = 2 weeks before first dose of study drug)
* Serious kidney injury, requiring dialysis
* Serious liver injury, and advanced liver diseases of Child-Pugh class B and C
* On medications that are strong cytochrome P450(CYP)3A inhibitors or inducers unless patients are willing and able to change to use of an equivalent medication that is not a strong CYP3A inhibitor or inducer
* Cardiac function and disease history which meets one or more of the following conditions:
* Any risk which may increase QTc interval prolongation, such as hypokalemia, hereditary long QT syndrome and taking drugs that can prolong QT interval
* Acute myocardial infarction = 6 months prior to Day 1
* Clinically significant arrhythmia = 6 months prior to Day 1
* Congestive heart failure = Grade 3 by New York Heart Association (NYHA) = 6 months prior to Day 1
* Cerebral vascular accident (CVA) = 6 months prior to Day 1
* Are pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/02/2022
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cabrini Malvern Hospital - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ai-Min Hui, MD, PhD
Address 0 0
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03690154