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A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

NCT ID: NCT01605526

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles

doxorubicin

Intervention Type DRUG

60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles

Interventions

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RO5045337

Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles

Intervention Type DRUG

doxorubicin

60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed soft tissue sarcoma
* Evaluable disease according to RECIST version 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Eligible for doxorubicin therapy
* Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade \</= 1 prior to start of study
* Adequate bone marrow, hepatic and renal function
* Patients with stable CNS metastases are eligible

Exclusion Criteria

* Previous treatment with limiting doses of doxorubicin
* Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment \</= 28 days from Day 1 dosing on study treatment
* History of seizure disorders or unstable CNS metastases
* Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
* Pregnant or breastfeeding women
* HIV positive patients who are currently receiving combination anti-retroviral therapy
* Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
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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Santa Monica, California, United States

Site Status

Boston, Massachusetts, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Bordeaux, , France

Site Status

Lyon, , France

Site Status

Toulouse, , France

Site Status

Villejuif, , France

Site Status

Countries

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United States France

Other Identifiers

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2011-006279-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28021

Identifier Type: -

Identifier Source: org_study_id