Trials / No Longer Available
No Longer AvailableNCT03114228
An Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML)
An Open-labeled, Multi-Center, Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) Who Are Eligible for Standard Induction and Consolidation Chemotherapy
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to gather and evaluate additional safety data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy and are without satisfactory treatment alternatives prior to the commercial availability\* and reimbursement of midostaurin during the regulatory approval process
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midostaurin | Midostaurin 50 mg (two 25 mg capsules) twice a day on days 8-21 |
Timeline
- First posted
- 2017-04-14
- Last updated
- 2019-10-15
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03114228. Inclusion in this directory is not an endorsement.