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)
NCT02568267 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 534
Last updated 2026-03-06
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
- DRUG
-
Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-19
- Primary Completion
- 2026-05-14
- Completion
- 2026-05-14
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- China
- France
- Germany
- Hong Kong
- Italy
- Japan
- Netherlands
- Poland
- Singapore
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma
NCT00733798 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
(Neo)Adjuvant BRAF/MEK Inhibition in pN1c Melanoma
NCT05767879 ·Status: RECRUITING ·Phase: PHASE2
-
Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
NCT01623869 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
NCT06263231 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
NCT03982173 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase
NCT02258607 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
NCT02069730 ·Status: COMPLETED ·Phase: NA
-
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
NCT07121829 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Investigate AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies
NCT00666081 ·Status: WITHDRAWN ·Phase: PHASE1
-
Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer
NCT00003062 ·Status: COMPLETED ·Phase: PHASE2
-
Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
NCT00720174 ·Status: COMPLETED ·Phase: PHASE1
-
Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
NCT05876806 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
NCT05241834 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
NCT03652077 ·Status: COMPLETED ·Phase: PHASE1
-
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
NCT00740636 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
NCT06066138 ·Status: RECRUITING ·Phase: PHASE1
-
Temozolomide in Treating Patients With Metastatic Non-small Cell Lung Cancer
NCT00006877 ·Status: COMPLETED ·Phase: PHASE2
-
Entinostat and Sorafenib Tosylate in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory or Relapsed Acute Myeloid Leukemia
NCT01159301 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Investigate the Absorption, Distribution, Metabolism and Elimination of [14C]GSK1120212
NCT01387204 ·Status: COMPLETED ·Phase: PHASE1
-
Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations
NCT02263898 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
NCT01379534 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
NCT04586270 ·Status: TERMINATED ·Phase: PHASE1
-
QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
NCT00563680 ·Status: COMPLETED ·Phase: PHASE2
-
Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
NCT03868423 ·Status: WITHDRAWN ·Phase: PHASE2
-
Lapatinib in Stage IV Melanoma With ERBB4 Mutations
NCT01264081 ·Status: TERMINATED ·Phase: PHASE2