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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)

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ClinicalTrials.gov Identifier: NCT02097810
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 21, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 28, 2014
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Phase 1: Dose-Limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of RXDX-101 ]
    Determine dose-limiting toxicities of RXDX-101.
  • Phase 1: Maximum Tolerated Dose (MTD) [ Time Frame: 28 days following first dose of RXDX-101 ]
    Determine MTD of RXDX-101
  • Phase 1: Recommended Phase 2 Dose (RP2D) [ Time Frame: Appox. 6 months ]
    Determine RP2D of RXDX-101.
  • Phase 2a: Objective response [ Time Frame: Approx. 2 years ]
    Proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator.
Change History Complete list of historical versions of study NCT02097810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Plasma concentrations of RXDX-101 [ Time Frame: Cycle 1 Days 1, 7, 14, 28 ]
  • Progression-Free Survival (PFS) [ Time Frame: Approx. 2 years ]
    Per RECIST v1.1 as assessed by Investigator.
  • Overall Survival (OS) [ Time Frame: Approx. 2 years ]
    Per RECIST v1.1 as assessed by Investigator.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors
Intervention  ICMJE Drug: Entrectinib
Other Name: TrkA/TrkB/TrkC/ROS1/ALK inhibitor
Study Arms  ICMJE Experimental: Entrectinib (RXDX-101)
Oral entrectinib (RXDX-101)
Intervention: Drug: Entrectinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
84
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
125
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02097810
Other Study ID Numbers  ICMJE RXDX-101-01
GO40784 ( Other Grant/Funding Number: Hoffmann-La Roche )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP