A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
1 other identifier
interventional
110
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2007
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 2, 2016
November 1, 2016
2.8 years
September 18, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AEs, laboratory parameters.
Throughout study
Secondary Outcomes (2)
Tumor assessments
day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
Pharmacokinetic profile
After first dose and last dose (or day 15) of cycles 1 and 2
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Administered orally daily at ascending doses to successive cohorts of patients
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- advanced and/or metastatic solid tumor malignancy;
- measurable or evaluable disease;
- ECOG performance status 0 or 1.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 98229, United States
MeSH Terms
Conditions
Interventions
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
September 18, 2007
First Posted
September 19, 2007
Study Start
November 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11