Trials / Active Not Recruiting
Active Not RecruitingNCT02568267
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)
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 534 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entrectinib | TrkA/B/C, ROS1, and ALK inhibitor |
Timeline
- Start date
- 2015-11-19
- Primary completion
- 2026-05-14
- Completion
- 2026-05-14
- First posted
- 2015-10-05
- Last updated
- 2026-03-06
Locations
130 sites across 16 countries: United States, Australia, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02568267. Inclusion in this directory is not an endorsement.