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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907954
Other study ID # IDE196-009
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 3, 2023
Est. completion date January 31, 2029

Study information

Verified date November 2023
Source IDEAYA Biosciences
Contact IDEAYA Clinical Trials
Phone 1 650-534-3616
Email IDEAYAClinicalTrials@ideayabio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma


Description:

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date January 31, 2029
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C

Locations

Country Name City State
Australia Alfred Health Melbourne Victoria
Australia St. Vincent's Health Sydney Sydney New South Wales
Canada Princess Margaret Cancer Centre Toronto Ontario
France Institute Curie Paris
Germany Charite Comprehensive Cancer Center Berlin
Germany University Hospital Essen - West German Cancer Center Essen
Italy Instituto Nazionale Tumori di Milano Milano
Italy Instituto Nazionale Tumori IRCCS - Fondazione Pascale Naples
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome
Netherlands Leiden University Medical Center Leiden
United Kingdom The Clatterbridge Cancer Centre NHS FT Liverpool
United Kingdom University College London Hospital - NHS Foundation Trust London
United States University of Texas Southwestern Medical Center Dallas Texas
United States Sarah Cannon Research Institute Denver Colorado
United States Duke University Health System Durham North Carolina
United States The Cancer and Hematology Centers Grand Rapids Michigan
United States UCLA Medical Center Los Angeles California
United States Northwell Manhasset New York
United States University of Miami Miami Florida
United States Sarah Cannon Research Institute Nashville Tennessee
United States Stanford Cancer Institute Palo Alto California
United States Thomas Jefferson University Philadelphia Pennsylvania
United States HonorHealth Research Institute Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
IDEAYA Biosciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall survival Evaluate patient survival status from date of first dose to end of follow-up, approximately 44 months
Primary Incidence of Adverse Events (AEs) and significant laboratory abnormalities Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline. from first dose to last dose of adjuvant therapy, approximately 12 months
Primary Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Primary Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary Evaluate tumor response to neoadjuvant IDE196 Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters) from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary Assessment of visual acuity loss Best corrected visual acuity loss over time from time of primary local therapy to one year after surgery, approximately 12 months
Secondary Rate of local disease recurrence Evaluate uveal melanoma progression or recurrence from date of primary local therapy to end of follow-up, approximately 36 months
Secondary Rate of metastatic disease Evaluate occurrence of metastatic uveal melanoma from date of primary local therapy to end of follow-up, approximately 36 months
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