Thoracic Oncology Program »  Research »  CC-15658

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Official Title:

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 18 Years and older Ignyta, Inc. RXDX-101-02
2015‐003385‐84
NCT02568267
Enrolling patients

Study Design:


Principal Investigator

Assistant Clinical Professor
Division of Hematology/Oncology
Department of Medicine

Clinical Research Coordinator

UCSF Helen Diller Family Comprehensive Cancer Center
(415) 514-6241 Phone
(415) 353-9721 Fax

Trial Summary

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Eligibility

Inclusion Criteria:
  • Histologically- or cytologically-confirmed diagnosis of locally advanced or
    metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement             - Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a
    gene rearrangement of interest may be eligible provided they meet all other
    inclusion/exclusion criteria
  • For patients enrolled via local molecular testing, an archival or fresh tumor tissue
    (unless medically contraindicated) is required to be submitted for independent
    central molecular testing at Ignyta's CLIA laboratory post-enrollment
  • Measurable or evaluable disease
  • Patients with CNS involvement, including leptomeningeal carcinomatosis, which is
    either asymptomatic or previously-treated and controlled, are allowed
  • Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,
    or ALK inhibitors in patients who have tumors that harbor those respective gene
    rearrangements)             - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
    prohibited.
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior
    chemotherapy or small molecule targeted therapy
  • At least 4 weeks must have elapsed since completion of antibody-directed therapy
  • Prior radiotherapy is allowed if more than 14 days have elapsed since the end of
    treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life
    expectancy of 4 weeks
  • Adequate organ function as defined per protocol
  • Ability to swallow entrectinib intact
  • Other protocol specified criteria
Exclusion Criteria:
  • Current participation in another therapeutic clinical trial
  • Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in
    patients who have tumors that harbor those respective gene rearrangements             - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
    prohibited.
  • History of other previous cancer that would interfere with the determination of
    safety or efficacy
  • Incomplete recovery from any surgery
  • History of non-pharmacologically induced prolonged QTc interval
  • History of additional risk factors for torsade de pointes
  • Peripheral neuropathy Grade ≥ 2
  • Known active infections
  • Active gastrointestinal disease or other malabsorption syndromes
  • Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase
    inhibitor-induced pneumonitis
  • Other protocol specified criteria

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 4/28/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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