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

November 1, 2016 updated by: Hoffmann-La Roche

A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
      • Lyon, France, 69373
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New York
      • New York, New York, United States, 10065
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 98229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RO5045337
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD and associated dose schedule
Time Frame: Every 28 days
Every 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: Event driven
Event driven
Dose-limiting toxicities.
Time Frame: Throughout study
Throughout study
Pharmacokinetic profile
Time Frame: Throughout study
Throughout study
Comparison safety and tolerability of daily versus twice daily dosing regimens
Time Frame: approximately 18 months
approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NO21280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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