A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies
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|ClinicalTrials.gov Identifier: NCT01567384|
Recruitment Status : Withdrawn (The sponsor withdrew support for the study before any patients were enrolled.)
First Posted : March 30, 2012
Last Update Posted : November 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer Neoplasms Tumors||Drug: OSI-906 and Pemetrexed||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||October 2013|
|Experimental: Combination therapy with OSI and Pemetrexed||
Drug: OSI-906 and Pemetrexed
Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability.
OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.
- Assessment of dose-limiting toxicity [ Time Frame: 21 days ]To define the dose of OSI-906 that can be combined with pemetrexed
- Progression-free survival [ Time Frame: 4-6 months ]Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
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): NCT01567384
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Suresh Ramalingam, MD||Emory University|