Trials / Approved For Marketing
Approved For MarketingNCT04204928
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Blueprint Medicines Corporation · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
Summary
This is a global, multicenter, open-label pre-approval access program to provide access to pralsetinib (BLU-667) until such time that pralsetinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pralsetinib (BLU-667) | Pralsetinib will be administered orally (PO) at a dose of 400 mg once daily (QD) in continuous 28 day cycles |
Timeline
- First posted
- 2019-12-19
- Last updated
- 2021-08-13
Source: ClinicalTrials.gov record NCT04204928. Inclusion in this directory is not an endorsement.