Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093600
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2004-10-06
Brief Title:
PKC412 Daunorubicin and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IB Open-Label Study to Determine the Safety and Pharmacokinetics of Twice Daily Oral Dosing of PKC412 Administered in Combinations Sequentially and Concomitantly With Daunorubicin and Cytarabine for Standard Induction Therapy and High Dose Cytarabine for Consolidation in Patients With Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2015-03
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:
RATIONALE PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs Drugs used in chemotherapy such as daunorubicin and cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die Combining PKC412 with chemotherapy may kill more cancer cells
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
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:
OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000389242 | OTHER | PDQ Physician Data Query | None |
| UCLA-0308139-01 | OTHER | None | None |