Clinical trialPhase 1 / Phase 2Withdrawn
OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas
- Outcome
- Stopped earlyStudy was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised. (Other)
- Phase
- Phase 1 / Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 participants
- Sites
- 2
- Primary outcomes
- Number of patients with adverse events as a measure of safety and tolerability; Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906
- Sponsor
- Other
- Results posted
- No
- Last update
- 26 June 2013
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Brief summary public domain (ClinicalTrials.gov)
OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth. Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
This study will be conducted in two parts: a phase I study and a phase II study. In both instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth, twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth, once a day, every day. At every visit subjects will have a physical exam and blood tests. An EKG will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done every 2 cycles (8 weeks). Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.