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)
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|ClinicalTrials.gov Identifier: NCT02097810|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Solid Tumors Metastatic Solid Tumors||Drug: Entrectinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 28, 2014|
|Estimated Primary Completion Date :||June 24, 2019|
|Estimated Study Completion Date :||June 24, 2019|
Experimental: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Other Name: TrkA/TrkB/TrkC/ROS1/ALK inhibitor
- 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 ]
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): NCT02097810
|United States, California|
|University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94158|
|United States, Colorado|
|University Of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Florida Cancer Specialists - Sarasota|
|Sarasota, Florida, United States, 34232|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 6351|
|Hospital Universitario Vall d'Hebron|
|Barcelona, Spain, 08035|
|Study Director:||Clinical Trials||Hoffmann-La Roche|