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A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

NCT ID: NCT00532090

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-08-31

Brief Summary

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This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.

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

RG4733

Intervention Type DRUG

Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule

2

Group Type EXPERIMENTAL

RG4733

Intervention Type DRUG

Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle

3

Group Type EXPERIMENTAL

RG4733

Intervention Type DRUG

Administered orally daily at ascending doses to successive cohorts of patients

Interventions

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RG4733

Administered orally daily at ascending doses to successive cohorts of patients

Intervention Type DRUG

RG4733

Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule

Intervention Type DRUG

RG4733

Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle

Intervention Type DRUG

Other Intervention Names

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RO4929097 RO4929097 RO4929097

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* advanced and/or metastatic solid tumor malignancy;
* measurable or evaluable disease;
* ECOG performance status 0 or 1.

Exclusion Criteria

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
* major surgery within 28 days of first receipt of study drug.
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

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NO21321

Identifier Type: -

Identifier Source: org_study_id