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)

June 7, 2021 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06531
        • Samsung Medical Center
  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • San Francisco, California, United States, 94158
        • University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists - Sarasota
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Drug: Entrectinib
Other Names:
  • TrkA/TrkB/TrkC/ROS1/ALK inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicity (DLT)
Time Frame: 28 days following first dose of entrectinib
Determine dose-limiting toxicities of entrectinib.
28 days following first dose of entrectinib
Maximum Tolerated Dose (MTD)
Time Frame: 28 days following first dose of entrectinib
Determine MTD of entrectinib
28 days following first dose of entrectinib
Recommended Phase 2 Dose (RP2D)
Time Frame: Approx. 6 months
Determine RP2D of entrectinib.
Approx. 6 months
Overall Response Rate (ORR) in Dose Expansion
Time Frame: Approx. 2 months
Per RECIST v1.1 as assessed by Investigator.
Approx. 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentrations of Entrectinib
Time Frame: Cycle 1 Days 1, 7, 14, 28
Cycle 1 Days 1, 7, 14, 28
Disease Control
Time Frame: Approx. 2 years
Per RECIST v1.1 as assessed by Investigator.
Approx. 2 years
Duration of Response
Time Frame: Approx. 2 years
Per RECIST v1.1 as assessed by Investigator.
Approx. 2 years
Overall Survival (OS)
Time Frame: Approx. 2 years
Approx. 2 years
Progression-Free Survival (PFS)
Time Frame: Approx. 2 years
Approx. 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 28, 2014

Primary Completion (ACTUAL)

June 2, 2020

Study Completion (ACTUAL)

June 2, 2020

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXDX-101-01
  • GO40784 (OTHER_GRANT: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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