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

NCT ID: NCT01641250

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Myelogenous Leukemia, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: RO5429083

Group Type EXPERIMENTAL

RO5429083

Intervention Type DRUG

Multiple escalating doses

Part B: RO5429083 + cytarabine

Group Type EXPERIMENTAL

RO5429083

Intervention Type DRUG

Multiple escalating doses

cytarabine

Intervention Type DRUG

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

Interventions

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RO5429083

Multiple escalating doses

Intervention Type DRUG

cytarabine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Marseille, , France

Site Status

Nantes, , France

Site Status

Paris, , France

Site Status

Toulouse, , France

Site Status

Aachen, , Germany

Site Status

Hamburg, , Germany

Site Status

Ulm, , Germany

Site Status

Bologna, Emilia-Romagna, Italy

Site Status

Countries

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France Germany Italy

Other Identifiers

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2012-001027-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28085

Identifier Type: -

Identifier Source: org_study_id