Clinical Trial: NCT02568267
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 NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-08-25 |
Study Overview
Brief 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
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
Intervention / Treatment
- Drug: Entrectinib
Other Study ID Numbers
- RXDX-101-02
- 2015-003385-84
- GO40782
- 2015
Start Date (Actual)
2015-11-19
Primary Completion Date (Estimated)
2027-06-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
534
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-08-25 |
Study Overview
Brief 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
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
Intervention / Treatment
- Drug: Entrectinib
Other Study ID Numbers
- RXDX-101-02
- 2015-003385-84
- GO40782
- 2015
Start Date (Actual)
2015-11-19
Primary Completion Date (Estimated)
2027-06-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
534
Study Type
Interventional
Phase
Phase 2