Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

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, Ovarian Epithelial Carcinoma, Renal Cell Brain Neoplasms Thyroid Neoplasms Salivary Gland Neoplasms Thyroid Cancer, Papillary 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

  • Univ Of California Irvine College Of Medicine; 300194620 in progress, not accepting new patients
    Orange California 92868 United States
  • City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics accepting new patients
    Duarte California 91010 United States
  • University of Southern California Medical Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02568267
Phase
Phase 2
Study Type
Interventional
Last Updated