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Completed

NCT Number: NCT01641250

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

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.

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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

Marseille, France

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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
  • 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

Treatment and study plan

RO5429083

Drug

Multiple escalating doses

Cytarabine

Drug

1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles

Primary outcomes

  1. Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)

    Time frame: approximately 24 months

Secondary outcomes

  1. Clinical response according to hematologic malignancy assessments

    Time frame: approximately 24 months

  2. Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 96 hrs post-dose

  3. Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3

  4. Pharmacodynamics: Biomarker levels in blood/bone marrow

    Time frame: Pre-dose and up to 96 hrs post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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).

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 16, 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.

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