Clinical trial
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic…
NCT00045942 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00045942 |
|---|---|
| Title | PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2) |
| Official title | An Open-label Phase II (Proof of Concept (POC)) Trial of PKC412 Monotherapy in Participants With Acute Myeloid Leukemia (AML) and Participants With High Risk Myelodysplastic Syndrome (MDS) (CPKC412A2104 Core); An Open-label, Randomized Phase II POC Trial in PKC412 in Participants With AML and… |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Acute Myeloid Leukemia, Myelodysplastic Syndromes |
| Intervention type | Drug |
| Interventions | Itraconazole, PKC412 |
| Enrollment | 144 |
| Start date | Jan 30, 2002 |
| Primary completion | Mar 27, 2008 |
| Completion | Mar 27, 2008 |
| First posted | Sep 18, 2002 |
| Last update posted | Aug 11, 2017 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: