A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors
A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
1 other identifier
interventional
106
2 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2007
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 16, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 2, 2016
November 1, 2016
4.9 years
November 15, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
MTD and associated dose schedule
Every 28 days
Secondary Outcomes (4)
Clinical response
Event driven
Dose-limiting toxicities.
Throughout study
Pharmacokinetic profile
Throughout study
Comparison safety and tolerability of daily versus twice daily dosing regimens
approximately 18 months
Study Arms (1)
1
EXPERIMENTALInterventions
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- solid tumor malignancies;
- failed prior therapies, or no standard therapy available;
- ECOG performance status of 0-2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 98229, United States
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Lyon, 69373, France
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 16, 2007
Study Start
December 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11