A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
November 1, 2016 updated by: Hoffmann-La Roche
Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
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
-
-
Colorado
-
Aurora, Colorado, United States, 80045
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
-
Boston, Massachusetts, United States, 02114
-
Boston, Massachusetts, United States, 02115
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
-
-
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;
- 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.
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
|
Administered orally daily at ascending doses to successive cohorts of patients
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
Other Names:
|
|
Experimental: 2
|
Administered orally daily at ascending doses to successive cohorts of patients
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
Other Names:
|
|
Experimental: 3
|
Administered orally daily at ascending doses to successive cohorts of patients
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
Other Names:
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
AEs, laboratory parameters.
Time Frame: Throughout study
|
Throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tumor assessments
Time Frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
|
day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
|
|
Pharmacokinetic profile
Time Frame: After first dose and last dose (or day 15) of cycles 1 and 2
|
After first dose and last dose (or day 15) of cycles 1 and 2
|
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, 2007
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 19, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NO21321
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.