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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Ignyta, Inc.
Sponsor:
Information provided by (Responsible Party):
Ignyta, Inc.
ClinicalTrials.gov Identifier:
NCT02097810
First received: March 21, 2014
Last updated: April 20, 2017
Last verified: April 2017
  Purpose

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 Intervention Phase
Locally Advanced Solid Tumors Metastatic Solid Tumors Drug: Entrectinib Phase 1

Study Type: Interventional
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

Further study details as provided by Ignyta, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 125
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)
Arms Assigned Interventions
Experimental: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Drug: Entrectinib
Other Name: TrkA/TrkB/TrkC/ROS1/ALK inhibitor

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097810

Contacts
Contact: Ignyta, Inc. 858-255-5959

Locations
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
Spain
Vall d'Hebron Institute of Oncology Active, not recruiting
Barcelona, Spain
Sponsors and Collaborators
Ignyta, Inc.
Investigators
Study Director: David Luo Ignyta, Inc.