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Trial record 1 of 1 for:    IDE196
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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 : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

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.


Condition or disease Intervention/treatment Phase
Metastatic Uveal Melanoma Cutaneous Melanoma Colorectal Cancer Other Solid Tumors Drug: IDE196 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : April 30, 2023


Arm Intervention/treatment
Experimental: Dose Escalation
IDE196 dosed orally, twice daily (BID) for each 28-day cycle
Drug: IDE196
IDE196 dosed orally, twice daily for each 28-day cycle

Experimental: Dose Expansion
RP2D
Drug: IDE196
IDE196 dosed orally, twice daily for each 28-day cycle




Primary Outcome Measures :
  1. Dose-limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of IDE196 ]
    Determine DLT of IDE196

  2. Maximum Tolerated Dose (MTD) [ Time Frame: 28 days following first dose of IDE196 ]
    Determine MTD of IDE196

  3. Recommended Phase 2 Dose (RP2D) [ Time Frame: Approx. 6 months ]
    Determine RP2D of IDE196

  4. Plasma Concentrations of IDE196 [ Time Frame: Cycle 1 Day 1 (C1D1), C1D15, C2D1, C3D1, C4D1, C5D1, C6D1 ]
    Pharmacokinetics of IDE196

  5. Overall Response Rate (ORR) in Dose Expansion [ Time Frame: Approx. 30 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Approx. 30 months ]
    RECIST version 1.1

  2. Disease Control [ Time Frame: Approx. 30 months ]
    RECIST version 1.1

  3. Numbers of Participants with Adverse Events [ Time Frame: Approx. 48 months ]
    Safety and tolerability of IDE196


Other Outcome Measures:
  1. Overall Survival [ Time Frame: Approx. 48 months ]
  2. Progression-Free Survival [ Time Frame: Approx. 48 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 instability-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
  • Allergy to mammalian meat or gelatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947385


Contacts
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Contact: Julie Hambleton, MD +1 650 262 3603 jhambleton@ideayabio.com

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sarah Melendez       Sarah.melendez@jefferson.edu   
Contact: Cynthia Y Perez, BS, CCRP       Cynthia.Perez@jefferson.edu   
United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: askSARAH    844-482-4812      
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Filip Janku, MD    713-792-6161    FJanku@mdanderson.org   
Australia, New South Wales
Westmead Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Matteo Carlino, MD    +61 288 905 200      
Contact    02 8890 5200      
Sponsors and Collaborators
IDEAYA Biosciences

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Responsible Party: IDEAYA Biosciences
ClinicalTrials.gov Identifier: NCT03947385     History of Changes
Other Study ID Numbers: IDE196-001
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Melanoma
Colorectal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases