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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05907954




Registration number
NCT05907954
Ethics application status
Date submitted
6/06/2023
Date registered
18/06/2023

Titles & IDs
Public title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Scientific title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Secondary ID [1] 0 0
IDE196-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveal Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

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

Experimental: darovasertib - IDE196 (darovasertib) oral open label


Treatment: Drugs: Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Timepoint [1] 0 0
from first dose to last dose of adjuvant therapy, approximately 12 months
Primary outcome [2] 0 0
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Timepoint [2] 0 0
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Primary outcome [3] 0 0
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Timepoint [3] 0 0
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary outcome [1] 0 0
Evaluate tumor response to neoadjuvant IDE196
Timepoint [1] 0 0
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary outcome [2] 0 0
Assessment of visual acuity loss
Timepoint [2] 0 0
from time of primary local therapy to one year after surgery, approximately 12 months
Secondary outcome [3] 0 0
Rate of local disease recurrence
Timepoint [3] 0 0
from date of primary local therapy to end of follow-up, approximately 36 months
Secondary outcome [4] 0 0
Rate of metastatic disease
Timepoint [4] 0 0
from date of primary local therapy to end of follow-up, approximately 36 months

Eligibility
Key inclusion criteria
* Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
* Able to dose orally
* ECOG Performance status of 0-1
* No other significant underlying ocular disease
* Adequate organ function
* Not pregnant/nursing or planning to become pregnant. Willing to use birth control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with a Protein Kinase C (PKC) inhibitor
* Concurrent malignant disease
* Active HIV infection or Hep B/C
* Malabsorption disorder
* Unable to discontinue prohibited medication
* Impaired cardiac function or clinically significant cardiac disease
* Any other condition which may interfere with study interpretation or results

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2029
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Health Sydney - Sydney
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Essen
Country [16] 0 0
Italy
State/province [16] 0 0
Milano
Country [17] 0 0
Italy
State/province [17] 0 0
Napoli
Country [18] 0 0
Italy
State/province [18] 0 0
Rome
Country [19] 0 0
Netherlands
State/province [19] 0 0
Leiden
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
IDEAYA Biosciences
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jasgit Sachdev, MD
Address 0 0
IDEAYA Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
IDEAYA Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1 650-534-3616
Fax 0 0
Email 0 0
[email protected]
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?

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/study/NCT05907954