- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635296
A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
November 1, 2016 updated by: Hoffmann-La Roche
A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)
This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia.
In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle.
In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle.
Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Marseille, France, 13273
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
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Glasgow, United Kingdom, G12 0YN
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Manchester, United Kingdom, M204BX
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New York
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Valhalla, New York, United States, 10595
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Texas
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San Antonio, Texas, United States, 78229
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including:
- Arm A: Patients who have not received prior standard induction chemotherapy, considered unsuitable for standard induction therapy
- Arm B: Patients who have failed their 1st or greater line of standard induction chemotherapy (primary refractory) or patients who originally achieved a complete response but are currently in first or greater relapse
- 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
- Adequate hepatic and renal function
- Patient must be willing to submit the blood sampling and bone marrow sampling for PK and PD analyses and exploratory biomarkers
Exclusion Criteria:
- History of allergic or toxic reactions attributed to cytarabine or a history of allergic reactions to components of the formulated product
- Current evidence of CNS leukemia
- Any severe and/or uncontrolled medical condition or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV-positive patients receiving combination anti-retroviral therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A: Previously untreated
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Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle
Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle
20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
1 gm/m2 iv, Days 1 to 6 of each 28-day cycle
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Experimental: B: Relapse/Refractory
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Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle
Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle
20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
1 gm/m2 iv, Days 1 to 6 of each 28-day cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum tolerated dose/dose-limiting toxicities
Time Frame: approximately 12 months
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approximately 12 months
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Safety: Incidence of adverse events
Time Frame: approximately 12 months
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approximately 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: Hematologic response
Time Frame: approximately 1 year
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approximately 1 year
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Pharmacodynamics: Biomarkers (MIC-1, protein, nucleic acid, other) from bone marrow/buccal tissue/blood
Time Frame: Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5)
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Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5)
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Pharmacokinetics: Cmax/area under the concentration-time curve
Time Frame: Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5
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Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
June 12, 2012
First Submitted That Met QC Criteria
July 4, 2012
First Posted (Estimate)
July 9, 2012
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- NP28023
- 2011-006252-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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