Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00014365|
Recruitment Status : Completed
First Posted : April 29, 2004
Last Update Posted : June 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: MKC-1||Phase 1|
OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients with locally advanced or metastatic solid tumors.
OUTLINE: This is a randomized, crossover study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1. After a 1-week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm II: Patients receive fed treatment as in arm I on day 1. After a 1-week washout period, patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 days.
PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||The Food-Effect Bioavailability Study of Ro 31-7453, a Novel Cell Cycle Inhibitor, in Stable Patient Volunteers With Solid Tumors|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014365
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven Soignet, MD||Memorial Sloan Kettering Cancer Center|