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).
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
44
3 countries
8
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2012
Actual (reported)July 16, 2012
Actual (reported)August 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 2015
Actual (reported)February 2015
Actual (reported)Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
approximately 24 months
Clinical response according to hematologic malignancy assessments
approximately 24 months
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Pre-dose and up to 96 hrs post-dose
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3
Pharmacodynamics: Biomarker levels in blood/bone marrow
Pre-dose and up to 96 hrs post-dose
Multiple escalating doses
1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles
Marseille, 13273, France
Nantes, 44093, France
Paris, 75475, France
Toulouse, 31059, France
Aachen, 52074, Germany
Hamburg, 20246, Germany
Ulm, 89081, Germany
Bologna, Emilia-Romagna, 40138, Italy
Clinical Trials
Hoffmann-La Roche
44 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2012
First Posted
July 16, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)Last Updated
November 2, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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