Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
No longer available
CT.gov ID
NCT03066661
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Official Title:
Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
-
Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
-
Willing and able to provide written, signed informed consent
-
Medically suitable for treatment with entrectinib (RXDX-101)
Exclusion Criteria:
- Currently enrolled in an ongoing clinical study with any other investigational agent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1-844-Startrk (782-7875) | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03066661
Other Study ID Numbers:
- Entrectinib (RXDX-101) - EAP
First Posted:
Feb 28, 2017
Last Update Posted:
Apr 26, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms: