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Last Updated: July 20, 2024

CLINICAL TRIALS PROFILE FOR MIDOSTAURIN


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All Clinical Trials for Midostaurin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00045942 ↗ 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 Kinas Completed Dana-Farber Cancer Institute Phase 1/Phase 2 2002-01-30 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 Investigator's 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.
NCT00045942 ↗ 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 Kinas Completed Memorial Sloan Kettering Cancer Center Phase 1/Phase 2 2002-01-30 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 Investigator's 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.
NCT00045942 ↗ 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 Kinas Completed University of California, Los Angeles Phase 1/Phase 2 2002-01-30 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 Investigator's 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Midostaurin

Condition Name

Condition Name for Midostaurin
Intervention Trials
Acute Myeloid Leukemia 20
Myelodysplastic Syndrome 5
Untreated Adult Acute Myeloid Leukemia 4
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Condition MeSH

Condition MeSH for Midostaurin
Intervention Trials
Leukemia, Myeloid, Acute 37
Leukemia, Myeloid 34
Leukemia 34
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Clinical Trial Locations for Midostaurin

Trials by Country

Trials by Country for Midostaurin
Location Trials
United States 219
Italy 58
Japan 33
Germany 18
Spain 13
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Trials by US State

Trials by US State for Midostaurin
Location Trials
Massachusetts 15
California 14
Florida 9
Texas 9
Michigan 9
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Clinical Trial Progress for Midostaurin

Clinical Trial Phase

Clinical Trial Phase for Midostaurin
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 1
Phase 2 21
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Clinical Trial Status

Clinical Trial Status for Midostaurin
Clinical Trial Phase Trials
Completed 17
Recruiting 14
Active, not recruiting 6
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Clinical Trial Sponsors for Midostaurin

Sponsor Name

Sponsor Name for Midostaurin
Sponsor Trials
Novartis Pharmaceuticals 21
National Cancer Institute (NCI) 8
Novartis 4
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Sponsor Type

Sponsor Type for Midostaurin
Sponsor Trials
Other 47
Industry 34
NIH 8
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