Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045942
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2002-09-16
Brief 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
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
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 Participants With High Risk MDS With Either Wild Type or Mutated FLT3 CPKC412A2104E1 and An Open-label Randomized Phase 1II POC Trial in PKC412 in Participants With AML and Participants With High Risk MDS With Either Wild Type or Mutated FLT3 CPKC412A2104E2
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CPKC412A2104 core had a 2 stage design In stage 1 eight participants were treated If at least one participant showed a clinical response four more participants were recruited to stage 2 The trial was to be stopped if no participants showed a response in stage 1 POC was achieved if at least 2 participants out of 12 responded In PKC412A2104E1 participants with AML or high risk MDS with wild-type or mutant FTL3 who had not previously received a FLT3 inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg midostaurin in 1 28-day cycle regimen Participants were to be treated until disease progression or the occurrence of unacceptable treatment-related toxicity PKC412A2104 E2 contained 2 dosing regimens 1 intra-participant midostaurin dose escalation and 2 midostaurin with itraconazole in participants with AML and high risk MDS irrespective of FLT3 status Eligible participants were alternately assigned to the regimens At the Investigators discretion intra-participant dose escalation was allowed for any previously enrolled CPKC412A2104E1 participant receiving midostaurin at the time of the approval of amendment 4 Participants were treated until the time of disease progression
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None