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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)

Status
Active
Cancer Type
Bile Duct Cancer
Breast Cancer
Colon/Rectal Cancer
Head and Neck Cancer
Lung Cancer
Melanoma
Neuroendocrine Tumor
Ovarian Cancer
Pancreatic Cancer
Sarcoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02568267
Protocol IDs
RXDX-101-02 (primary)
NCI-2015-01848
Study Sponsor
Hoffmann-La Roche

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

  1. Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
  2. 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
  3. Measurable or evaluable disease
  4. Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
  5. 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)
  6. 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.
  7. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
  8. At least 4 weeks must have elapsed since completion of antibody-directed therapy
  9. Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
  10. Eastern Cooperative Oncology Group (ECOG) performance status = 2 and minimum life expectancy of 4 weeks
  11. Adequate organ function as defined per protocol
  12. Ability to swallow entrectinib intact
  13. Other protocol specified criteria

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology


3320 Old Jefferson Road
Building 700
Athens, GA 30607
706-353-2990 x279
www.universitycancer.com

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.