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A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

NCT ID: NCT00559533

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-11-30

Brief Summary

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This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Detailed Description

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Conditions

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Neoplasms

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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1

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

Interventions

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RO5045337

Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* solid tumor malignancies;
* failed prior therapies, or no standard therapy available;
* ECOG performance status of 0-2.

Exclusion Criteria

* patients receiving any other agent or therapy to treat their malignancy;
* pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
* clinically significant cardiovascular disease.
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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Aurora, Colorado, United States

Site Status

Boston, Massachusetts, United States

Site Status

New York, New York, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Bordeaux, , France

Site Status

Lyon, , France

Site Status

Countries

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United States France

Other Identifiers

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NO21280

Identifier Type: -

Identifier Source: org_study_id