Back to resultsA Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Primary Purpose
Myelogenous Leukemia, Acute
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5429083
cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Myelogenous Leukemia, Acute
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade < 2, except alopecia
- Adequate hepatic and renal function
- Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers
Exclusion Criteria:
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
- History of allergic reactions attributed to components of cytarabine and/or the formulated product
- Current evidence of CNS leukemia
- Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
- Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
- Uncontrollable intercurrent illness
- Pregnant or breast-feeding women
HIV-positive patients receiving anti-retroviral therapy
- Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: RO5429083
Part B: RO5429083 + cytarabine
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
Secondary Outcome Measures
Clinical response according to hematologic malignancy assessments
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Pharmacodynamics: Biomarker levels in blood/bone marrow
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01641250
Brief Title
A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Official Title
Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelogenous Leukemia, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: RO5429083
Arm Type
Experimental
Arm Title
Part B: RO5429083 + cytarabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5429083
Intervention Description
Multiple escalating doses
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
Time Frame
approximately 24 months
Secondary Outcome Measure Information:
Title
Clinical response according to hematologic malignancy assessments
Time Frame
approximately 24 months
Title
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Time Frame
Pre-dose and up to 96 hrs post-dose
Title
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Time Frame
Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3
Title
Pharmacodynamics: Biomarker levels in blood/bone marrow
Time Frame
Pre-dose and up to 96 hrs post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade < 2, except alopecia
Adequate hepatic and renal function
Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers
Exclusion Criteria:
Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
History of allergic reactions attributed to components of cytarabine and/or the formulated product
Current evidence of CNS leukemia
Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
Uncontrollable intercurrent illness
Pregnant or breast-feeding women
HIV-positive patients receiving anti-retroviral therapy
Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Aachen
ZIP/Postal Code
52074
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
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A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
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