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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 : Completed
First Posted : March 27, 2014
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
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
Actual Study Start Date : July 28, 2014
Actual Primary Completion Date : June 2, 2020
Actual Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Entrectinib

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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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 ClinicalTrials.gov identifier (NCT number): NCT02097810


Locations
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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
Tennessee Oncology
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02097810    
Other Study ID Numbers: RXDX-101-01
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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
 Entrectinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action