A Study of RO5045337 in Patients With Solid Tumors
An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
1 other identifier
interventional
76
1 country
5
Brief Summary
This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2010
Typical duration for phase_1
5 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
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 16, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 2, 2016
November 1, 2016
2.8 years
July 15, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Examination of potential food-effect on pharmacokinetics of RO5045337
3 weeks
Evaluation of relative bioavailability of RO5045337
3 weeks
Secondary Outcomes (2)
Evaluation of safety and tolerability of RO5045337
3 weeks
Evaluation of pharmacodynamics and biomarkers
3 weeks
Study Arms (4)
A
ACTIVE COMPARATORB
EXPERIMENTALC
EXPERIMENTALD
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/=18 years of age
- Histologically confirmed solid tumor
- Life expectancy of \>/=12 weeks
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
You may not qualify if:
- Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start
- Patients with pre-existing gastro-intestinal disorder
- Patients with uncontrolled intercurrent illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
Kansas City, Kansas, 66160-7330, United States
Unknown Facility
Kensignton, Maryland, 20895, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
San Antonio, Texas, 98229, United States
Related Publications (1)
Patnaik A, Tolcher A, Beeram M, Nemunaitis J, Weiss GJ, Bhalla K, Agrawal M, Nichols G, Middleton S, Beryozkina A, Sarapa N, Peck R, Zhi J. Clinical pharmacology characterization of RG7112, an MDM2 antagonist, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):587-95. doi: 10.1007/s00280-015-2830-8. Epub 2015 Jul 26.
PMID: 26210682DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
July 16, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11