Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1)
Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment.
Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.
|Locally Advanced Solid Tumors Metastatic Solid Tumors||Drug: Entrectinib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multicenter, Open-Label Study of Oral Entrectinib (RXDX-101) in Adult Patients With Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations|
- Dose-Limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of entrectinib ]Determine dose-limiting toxicities of entrectinib.
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 days following first dose of entrectinib ]Determine MTD of entrectinib
- Recommended Phase 2 Dose (RP2D) [ Time Frame: Approx. 6 months ]Determine RP2D of entrectinib.
- Overall Response Rate (ORR) in Dose Expansion [ Time Frame: Approx. 2 months ]Per RECIST v1.1 as assessed by Investigator.
- Plasma Concentrations of Entrectinib [ Time Frame: Cycle 1 Days 1, 7, 14, 28 ]
- Disease Control [ Time Frame: Approx. 2 years ]Per RECIST v1.1 as assessed by Investigator.
- Duration of Response [ Time Frame: Approx. 2 years ]Per RECIST v1.1 as assessed by Investigator.
- Overall Survival (OS) [ Time Frame: Approx. 2 years ]
- Progression-Free Survival (PFS) [ Time Frame: Approx. 2 years ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Other Name: TrkA/TrkB/TrkC/ROS1/ALK inhibitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097810
|Contact: Ignyta, Inc.||858-255-5959|
|United States, California|
|Chao Family Comprehensive Cancer Center at UC Irvine||Active, not recruiting|
|Irvine, California, United States|
|United States, Colorado|
|University of Colorado Cancer Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown||Active, not recruiting|
|Washington, D.C., District of Columbia, United States|
|United States, Florida|
|Sarah Cannon Research Institute||Recruiting|
|Sarasota, Florida, United States, 34232|
|United States, Massachusetts|
|Massachusetts General Hospital/Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, Tennessee|
|Sarah Cannon Research Institute||Active, not recruiting|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center||Active, not recruiting|
|Houston, Texas, United States, 77030|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Vall d'Hebron Institute of Oncology||Active, not recruiting|
|Study Director:||David Luo||Ignyta, Inc.|