PKC412 and 5-Azacytidine
|ClinicalTrials.gov Identifier: NCT01202877|
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: 5-azacytidine Drug: PKC412||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Combination of PKC412 and 5-Azacytidine for the Treatment of Patients With Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: 5-azacytidine + PKC412
5-azacytidine 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.
Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
Other Name: Midostaurin
- Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 [ Time Frame: 6 months ]Criteria for response per international working group for Myelodysplastic Syndrome (MDS) & acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response.
- Overall Response (OR) Within 6 Months [ Time Frame: 6 Months ]Overall response defined as percentage of participants with response as follows: (OR = CR [complete response (CR) rate] + CRi [complete remission with incomplete count recovery] + PR [partial remission] + HI [hematologic improvement]) within 6 months of treatment initiation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202877
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Cortes, MD||M.D. Anderson Cancer Center|