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Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

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ClinicalTrials.gov Identifier: NCT03947385
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 15, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Dose-limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of IDE196 ]
    Determine DLT of IDE196
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 days following first dose of IDE196 ]
    Determine MTD of IDE196
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Approx. 6 months ]
    Determine RP2D of IDE196
  • Plasma Concentrations of IDE196 [ Time Frame: Cycle 1 Day 1 (C1D1), C1D15, C2D1, C3D1, C4D1, C5D1, C6D1 ]
    Pharmacokinetics of IDE196
  • Overall Response Rate (ORR) in Dose Expansion [ Time Frame: Approx. 30 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03947385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Duration of Response [ Time Frame: Approx. 30 months ]
    RECIST version 1.1
  • Disease Control [ Time Frame: Approx. 30 months ]
    RECIST version 1.1
  • Numbers of Participants with Adverse Events [ Time Frame: Approx. 48 months ]
    Safety and tolerability of IDE196
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2019)
  • Overall Survival [ Time Frame: Approx. 48 months ]
  • Progression-Free Survival [ Time Frame: Approx. 48 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Official Title  ICMJE A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Brief Summary

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.

Phase 1 (dose escalation) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Uveal Melanoma
  • Cutaneous Melanoma
  • Colorectal Cancer
  • Other Solid Tumors
Intervention  ICMJE Drug: IDE196
IDE196 dosed orally, twice daily for each 28-day cycle
Study Arms  ICMJE
  • Experimental: Dose Escalation
    IDE196 dosed orally, twice daily (BID) for each 28-day cycle
    Intervention: Drug: IDE196
  • Experimental: Dose Expansion
    RP2D
    Intervention: Drug: IDE196
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be ≥18 years of age
  • Diagnosis of one of the following:

    • MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Or
    • Non-MUM: Advanced cutaneous melanoma, colorectal cancer, or other solid tumor that has progressed following prior standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 hotspot mutation
  • Measurable disease
  • Eastern Cooperative Oncology Group ≤1
  • Adequate organ function at screening
  • Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential

Exclusion Criteria:

  • Another malignancy
  • Known microsatellite instable - high (MSI-H) tumors
  • Adverse events from prior anti-cancer therapy that have not resolved
  • Untreated or symptomatic central nervous system metastases
  • Human immunodeficiency virus, acquired immunodeficiency syndrome related illness, hepatitis B virus, or hepatitis C virus
  • Recent surgery or radiotherapy
  • Females who are pregnant or breastfeeding
  • Impaired cardiac function
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Hambleton, MD +1 650 262 3603 jhambleton@ideayabio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947385
Other Study ID Numbers  ICMJE IDE196-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IDEAYA Biosciences
Study Sponsor  ICMJE IDEAYA Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IDEAYA Biosciences
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP