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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)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02097810
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
Ignyta, Inc.

Brief Summary:

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)
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
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Drug: Entrectinib
Other Name: TrkA/TrkB/TrkC/ROS1/ALK inhibitor

Primary Outcome Measures :
  1. Dose-Limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of entrectinib ]
    Determine dose-limiting toxicities of entrectinib.

  2. Maximum Tolerated Dose (MTD) [ Time Frame: 28 days following first dose of entrectinib ]
    Determine MTD of entrectinib

  3. Recommended Phase 2 Dose (RP2D) [ Time Frame: Approx. 6 months ]
    Determine RP2D of entrectinib.

  4. Overall Response Rate (ORR) in Dose Expansion [ Time Frame: Approx. 2 months ]
    Per RECIST v1.1 as assessed by Investigator.

Secondary Outcome Measures :
  1. Plasma Concentrations of Entrectinib [ Time Frame: Cycle 1 Days 1, 7, 14, 28 ]
  2. Disease Control [ Time Frame: Approx. 2 years ]
    Per RECIST v1.1 as assessed by Investigator.

  3. Duration of Response [ Time Frame: Approx. 2 years ]
    Per RECIST v1.1 as assessed by Investigator.

  4. Overall Survival (OS) [ Time Frame: Approx. 2 years ]
  5. Progression-Free Survival (PFS) [ Time Frame: Approx. 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02097810

Contact: Ignyta, Inc. 858-255-5959

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Sponsors and Collaborators
Ignyta, Inc.
Study Director: David Luo Ignyta, Inc.