Spots Global Cancer Trial Database for Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
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Trial Identification
Brief Title: Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Official Title: A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Study ID: NCT03947385
Study Description
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 - monotherapy) 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. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib 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. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib 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. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute, Scottsdale, Arizona, United States
UCLA Medical Center, Los Angeles, California, United States
San Francisco Oncology Associates, San Francisco, California, United States
Florida Cancer Specialist South, Fort Myers, Florida, United States
Florida Cancer Specialist North, Saint Petersburg, Florida, United States
Mosaic Life Care, Saint Joseph, Missouri, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati Cancer Center, Cincinnati, Ohio, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
The Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Westmead Hospital, Sydney, New South Wales, Australia
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: Jasgit Sachdev, MD
Affiliation: jsachdev@ideayabio.com
Role: STUDY_DIRECTOR
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