A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia (VIAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02527174|
Recruitment Status : Withdrawn (Volasertib no longer available)
First Posted : August 18, 2015
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Leukemia, Monocytic, Acute Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute||Drug: Volasertib Drug: Idarubicin Drug: Cytarabine||Phase 1|
Main inclusion criteria:
- AML, any subtype except acute promyelocytic leukemia (APL)
At least one of the following features:
i. Age 18-75 with adverse risk cytogenetics ii. Age 18-75 with antecedent myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPD), or therapy-related AML iii. Age 60-75, regardless of risk category
- No prior therapy for AML other than hydroxyurea
- Judged by treating physician to be medically fit for induction chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
- Normal left ventricular ejection fraction
Subjects will receive induction chemotherapy consisting of idarubicin 12 mg/m2 on Days 1-3 plus cytarabine 200 mg/m2 (age 18-59) or 100 mg/m2 (age 60-75) as a continuous IV infusion x 7 days. Volasertib will be administered on day 4 in a dose-escalation schedule, using a standard 3+3 dose escalation design, over 3 dose levels. Once the MTD has been determined, an additional dose expansion cohort will be accrued.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Volasertib Combined With Standard Induction Chemotherapy for Previously Untreated Patients With Acute Myeloid Leukemia (VIAC)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Study treatment arm
Will receive volasertib combined with idarubicin plus cytarabine in a 3+7 schedule as induction chemotherapy. Volasertib dose will be given on day 4 in a dose escalation schedule over 3 dose levels (140 mg/m2, 170 mg/m2, 200 mg/m2) in successive cohorts.
Non-hematologic toxicity will be determined using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria for adverse events. Hematologic toxicity will be determined by days to absolute neutrophil count (ANC) and platelet recovery.
Addition of single dose of volasertib intravenously (IV) on Day 4 of treatment protocol.
Other Name: BI 6727
Given IV daily on Days 1-3 of treatment protocol.
Given IV daily as 24-hour continuous infusion on Day 1-7 of treatment protocol.
Other Name: Ara-C
- Toxicity profile [ Time Frame: Participants will be followed for duration of induction cycle (expected time 28-35 days) for toxicity. ]Non-hematologic toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Hematologic toxicities will be assessed by determining number of days to neutrophil (ANC) recovery to >0.5 x10(9)/L or platelet recovery to >20 x10(9)/L.
- Dose-limiting toxicity (DLT) [ Time Frame: Participants will be followed for duration of induction cycle (expected time 28-35 days) for DLT assessment. ]DLT is defined as grade 3-4 non-hematologic toxicity (except grade 3 nausea, vomiting, mucositis or creatinine elevation due to tumor lysis syndrome, and grade 3-4 neutropenic infections and electrolyte abnormalities) using CTCAE version 4.0.Hematologic DLT is defined as ANC recovery to >0.5 x10(9)/L or platelet recovery to >20 x10(9)/L of > 42 days.
- Maximum tolerated dose (MTD) [ Time Frame: Determined after completion of dose-escalation phase of study, which will take approx. 12-15 months. ]MTD is defined as maximum dose of volasertib associated with < 2/6 DLTs at a given dose level.
- Complete response rate of regimen [ Time Frame: Responses will be determined at hematologic recovery (Day 28 or greater, up to Day 60). ]Complete response (CR) defined as <5% marrow blasts with ANC > 1.0 x10(9)/L and platelets >100 x 10(9)/L, with no extramedullary disease. CRi defined as same, but ANC <1.0 and/or platelets <100.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527174
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2G3|
|Principal Investigator:||Joseph Brandwein, MD||University of Alberta|