Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:27 PM
Study NCT ID:
NCT01016860
Status:
TERMINATED
Last Update Posted:
2013-10-21
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSI-906 and Irinotecan in Patients With Advanced Cancer
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was discontinued due to a shown lack of efficacy in the investigational agent
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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. "The FDA is the U.S. government agency that reviews the results of research of drugs and decides if it can be sold in the U.S. OSI-906 has been given to over 185 people with cancer.
Detailed Description:
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?
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?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-03204 | OTHER | National Cancer Institute | View |