Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Collin Blakely

Description

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.

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

Keywords

Breast Cancer Cholangiocarcinoma Colorectal Cancer Head and Neck Neoplasms Lymphoma, Large-Cell, Anaplastic Melanoma Neuroendocrine Tumors Non-Small Cell Lung Cancer Ovarian Cancer Pancreatic Cancer Papillary Thyroid Cancer Primary Brain Tumors Renal Cell Carcinoma Sarcomas Salivary Gland Cancers Adult Solid Tumor Entrectinib RXDX-101 TrkA TrkB TrkC NTRK1 NTRK2 NTRK3 ROS1 ALK Trk Fusions NTRK Gene Rearrangements ROS1 Fusions ROS1 Gene Rearrangements ALK Fusions ALK Gene Rearrangements Basket study Renal cell cancer Head & Neck cancers Anaplastic Large Cell Lymphoma Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Pancreatic Neoplasms Sarcoma Ovarian Neoplasms Carcinoma, Renal Cell Brain Neoplasms Thyroid Neoplasms Salivary Gland Neoplasms Carcinoma NTRK1/2/3-rearranged NSCLC ROS1-rearranged NSCLC NTRK/1/2/3-rearranged mCRC ROS1-rearranged mCRC ALK-rearranged mCRC NTRK1/2/3-rearranged other solid tumor ROS1-rearranged other solid tumor ALK-rearranged other solid tumor

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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/

You CAN'T join if...

  • 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

Locations

  • UCSF Mount Zion Medical Ctr accepting new patients
    San Francisco California 94115 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States
  • University of Southern California Medical Center accepting new patients
    Los Angeles California 90033 United States
  • City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics accepting new patients
    Duarte California 91010 United States
  • Univ Of California Irvine College Of Medicine; 300194620 accepting new patients
    Orange California 92868 United States
  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley accepting new patients
    Las Vegas Nevada 89169 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02568267
Phase
Phase 2
Lead Scientist
Collin Blakely
Study Type
Interventional
Last Updated
August 17, 2018