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A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

NCT01635296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-11-02

No results posted yet for this study

Summary

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.

Conditions

  • Myelogenous Leukemia, Acute

Interventions

DRUG

RO5045377

Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle

DRUG

RO5045377

Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle

DRUG

cytarabine

20 mg/m2 sc, Days 1 to 10 of each 28-day cycle

DRUG

cytarabine

1 gm/m2 iv, Days 1 to 6 of each 28-day cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Canada
  • France
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635296 on ClinicalTrials.gov