OSI-906 and Irinotecan in Patients With Advanced Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/IB Study of OSI-906 and Irinotecan in Patients With Advanced Cancer With Expanded Cohorts of Patients With Colorectal Cancer Stratified by the OSI-906 Integrated Classifier|
- Maximum tolerated dose (MTD) and the recommend phase II dose (RP2D) for the combination of irinotecan and OSI-906 in patients with advanced cancer. [ Time Frame: Up to 28 days of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: OSI-906 and/or irinotecan
Dose Escalation Phase: Treatment for Cycle 1 will commence on Day -3 of a 21-day cycle (3 weeks) when a single dose OSI-906 is given with full pharmacokinetics(PK) sampling at predetermined time points. Irinotecan will be administered intravenously over 90 minutes on Day 1 and Day 8 with full PK sampling on Day 1. The institution of oral dosing of OSI-906 2-4, 8-10, 15-17 (for cycle 1 only) will be given followed by full PK sampling of both drugs on Day 8. Pre-dose samples of OSI-906 will be drawn on Cycle 1 Days 8, 10, 15, 17 and Cycle 2 Days 1, 8, 10, 15 and 17. For Cycle 2 and thereafter, both drugs will be administered starting on Day 1.
OSI-906 will be given orally in tablets for one dose starting on Cycle 1 Day-3 then on Cycle 1 Day 2-4, 8-10 and 15-17. Cycle is 21 days. Subsequent cycles, dosing will start be Day 1-3, 8-10 and 15-17
Other Name: LinsitinibDrug: irinotecan
Irinotecan will be administered IV over 90 minutes on Day 1 and 8 of a 21-day cycle
Other Name: Camptosar
This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being looked at to see if it could be a treatment for advanced cancer.
Subjects will also receive a drug called irinotecan (also called Camptosar®). This drug is FDA approved for the treatment of metastatic colon cancer and some other types of cancer. The study drug and irinotecan have never been tested together in humans. It is unknown if the combination will be safe and/or effective in the treatment of human cancers.
The purpose of this study is to find the answers to the following research questions:
- What is the highest dose of the study drug that can be given to subjects in combination with irinotecan without causing side effects that are too severe?
- How is the combination of the study drug and irinotecan handled in the blood of subjects with advanced cancer? Does either the study drug or irinotecan have an effect on how the other works?
- What are the most common side effects of the study drug and irinotecan when given together to subjects with advanced cancer?
- Is the combination of the study drug and irinotecan effective in stopping the growth or shrinking the size of your tumor?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016860
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Stephen Leong, M.D||University of Colorado, Denver|