A Study of OSI-906 and Irinotecan in Patients With Advanced Cancer With Expanded Cohorts of Patients With KRAS Mutant Colorectal Cancer
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 70 people with cancer.
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?
Study Design
Masking: Open Label
Conditions
Colorectal Cancer
Intervention
Treatment with OSI-906 and/or irinotecan
Location
University of Colorado Denver
Aurora
Colorado
United States
80045
Status
Recruiting
Source
University of Colorado, Denver
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01016860
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:17:50-0400
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Medical and Biotech [MESH] Definitions
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Genes, Mcc
Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
Genes, Dcc
Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.
Colorectal Neoplasms, Hereditary Nonpolyposis
A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.
Tumor Suppressor Protein P53
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
