Trials / No Longer Available
No Longer AvailableNCT02547675
Rociletinib (CO-1686) USA Expanded Access Program
An Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Clovis Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
Detailed description
This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rociletinib | Rociletinib will be administered to patients orally |
Timeline
- First posted
- 2015-09-11
- Last updated
- 2018-09-25
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02547675. Inclusion in this directory is not an endorsement.