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A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

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Roche

Status and phase

Completed
Phase 1

Conditions

Myelogenous Leukemia, Acute

Treatments

Drug: cytarabine
Drug: RO5429083

Study type

Interventional

Funder types

Industry

Identifiers

NCT01641250
2012-001027-12 (EudraCT Number)
BP28085

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Part A: RO5429083
Experimental group
Treatment:
Drug: RO5429083
Part B: RO5429083 + cytarabine
Experimental group
Treatment:
Drug: cytarabine
Drug: RO5429083

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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