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

NCT ID: NCT01635296

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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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A: Previously untreated

Group Type EXPERIMENTAL

RO5045377

Intervention Type DRUG

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

cytarabine

Intervention Type DRUG

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

B: Relapse/Refractory

Group Type EXPERIMENTAL

RO5045377

Intervention Type DRUG

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

cytarabine

Intervention Type DRUG

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

Interventions

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RO5045377

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

Intervention Type DRUG

RO5045377

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

Intervention Type DRUG

cytarabine

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

Intervention Type DRUG

cytarabine

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

Intervention Type DRUG

Eligibility Criteria

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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
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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Valhalla, New York, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

San Antonio, Texas, United States

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Marseille, , France

Site Status

Bologna, Emilia-Romagna, Italy

Site Status

Glasgow, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States Canada France Italy United Kingdom

Other Identifiers

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2011-006252-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28023

Identifier Type: -

Identifier Source: org_study_id