PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00093600
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2004-02-29
2011-06-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.
Detailed Description
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Primary
* Determine the safety and tolerability of PKC412 administered sequentially or concurrently with induction chemotherapy comprising daunorubicin and cytarabine followed by consolidation therapy comprising high-dose cytarabine in patients with newly diagnosed acute myeloid leukemia.
* Compare the pharmacokinetics of these regimens in these patients.
Secondary
* Determine the efficacy of these regimens, in terms of response rate, disease-free survival, and overall survival, in these patients.
* Correlate genetic variation in drug metabolism genes, leukemia genes, and drug target genes with response in patients treated with these regimens.
OUTLINE: This is an open-label, multicenter study. Patients are alternately assigned to 1 of 2 induction treatment groups.
* Induction therapy:
* Group I (sequential therapy): Patients receive daunorubicin IV over 30 minutes on days 1-3, cytarabine IV continuously on days 1-7, and oral PKC412 twice daily on days 8-21 in the absence of disease progression or unacceptable toxicity.
* Group II (concurrent therapy): Patients receive daunorubicin and cytarabine as in group I and oral PKC412 twice daily on days 1-7 and 15-21 in the absence of disease progression or unacceptable toxicity.
In both groups, patients are evaluated on day 28. Patients with persistent disease receive a second induction course comprising daunorubicin IV over 30 minutes on days 1 and 2, cytarabine IV continuously on days 1-5, and oral PKC412 on the same schedule as their assigned treatment group. Patients with a complete response after course 1 or course 2 proceed to consolidation therapy.
* Consolidation therapy: Patients in both groups receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5 and oral PKC412 on the same schedule as their assigned treatment group. Treatment repeats every 28-42 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of consolidation therapy, patients in both groups continue to receive PKC412 alone, according to their assigned treatment group, every 28-42 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PKC412 administered sequentially
twice daily oral dosing of PKC412 administered sequentially
midostaurin
PKC412 administered concomitantly
PKC412 administered concomitantly with standard induction daunorubicin and cytarabine therapy followed by high-dose consolidation therapy with cytarabine
cytarabine
daunorubicin hydrochloride
midostaurin
Interventions
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cytarabine
daunorubicin hydrochloride
midostaurin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No gastrointestinal impairment or disease that would preclude absorption of study drugs
* No uncontrolled diabetes
* No active uncontrolled infection
* No other disease, except carcinoma in situ, that would preclude study participation
* No other severe or uncontrolled medical condition that would preclude study participation
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 5 days since prior growth factors
* No concurrent biological response modifiers
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy except radiation castration
* No concurrent radiotherapy
Surgery
* More than 14 days since prior surgical procedure except central venous catheter placement or other minor procedure (e.g., skin biopsy)
Other
* More than 30 days since prior investigational agents
* No other concurrent anticancer agents
* No other concurrent investigational drugs
18 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Investigative Site, MD
Role: STUDY_DIRECTOR
Novartis Investigative Site
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Mainz, , Germany
Countries
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References
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Stone RM, Fischer T, Paquette R, Schiller G, Schiffer CA, Ehninger G, Cortes J, Kantarjian HM, DeAngelo DJ, Huntsman-Labed A, Dutreix C, del Corral A, Giles F. Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia. Leukemia. 2012 Sep;26(9):2061-8. doi: 10.1038/leu.2012.115. Epub 2012 Apr 27.
Related Links
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Results for CPKC412A2106 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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UCLA-0308139-01
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000389242
Identifier Type: OTHER
Identifier Source: secondary_id
NOVARTIS-CPKC412A2106
Identifier Type: -
Identifier Source: org_study_id