Skip to main content
OpenTrials
Completed

NCT Number: NCT01635296

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelogenous Leukemia, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5045377

Drug

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

Cytarabine

Drug

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

Primary outcomes

  1. Maximum tolerated dose/dose-limiting toxicities

    Time frame: approximately 12 months

  2. Safety: Incidence of adverse events

    Time frame: approximately 12 months

Secondary outcomes

  1. Efficacy: Hematologic response

    Time frame: approximately 1 year

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.