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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02097810|
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : June 9, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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)|
|Actual Enrollment :||84 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|
|Actual Primary Completion Date :||June 2, 2020|
|Actual Study Completion Date :||June 2, 2020|
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alteration.
- Measurable disease according to RECIST version 1.1.
- Prior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs.
- Prior radiotherapy is allowed
- Patients with controlled asymptomatic central nervous system involvement are allowed.
- Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Adult patients age 18 years or older.
- Life expectancy of at least 3 months.
Key Exclusion Criteria:
- Current participation in another therapeutic clinical trial.
- Prior treatment with entrectinib.
- History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds).
- History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome).
- Known active infections (bacterial, fungal, viral including HIV positivity).
- Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis.
- Peripheral neuropathy ≥ Grade 2.
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|
|UC Irvine Medical Center|
|Orange, California, United States, 92868|
|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, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|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|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 06531|
|Study Director:||Clinical Trials||Hoffmann-La Roche|
|Responsible Party:||Hoffmann-La Roche|
|Other Study ID Numbers:||
GO40784 ( Other Grant/Funding Number: Hoffmann-La Roche )
|First Posted:||March 27, 2014 Key Record Dates|
|Last Update Posted:||June 9, 2021|
|Last Verified:||June 2021|
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action