- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00773526
A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
November 1, 2016 updated by: Hoffmann-La Roche
An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors.
In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days.
The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose.
In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily.
The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
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
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Villejuif, France, 94805
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Barcelona, Spain, 08003
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Sutton, United Kingdom, SM2 5PT
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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;
- advanced and/or metastatic cancer not amenable to standard therapy;
- any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
- measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);
- ECOG performance status 0-1.
Exclusion Criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
- known past or present CNS metastases;
- acute or chronic infection.
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: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1).
Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum tolerated dose (Part 1)
Time Frame: Throughout study
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Throughout study
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Tumor assessments (Part 2)
Time Frame: Event driven
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Event driven
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).
Time Frame: Throughout study
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Throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2008
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
October 15, 2008
First Submitted That Met QC Criteria
October 15, 2008
First Posted (Estimate)
October 16, 2008
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
- NO21895
- 2008-002298-11
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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