Pancreatic Cancer, Metastatic Clinical Trial
Official title:
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas
| NCT number | NCT01600807 |
| Other study ID # | 11-148 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 1/Phase 2 |
| First received | August 8, 2011 |
| Last updated | June 25, 2013 |
| Verified date | June 2013 |
| Source | Dana-Farber Cancer Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Metastatic pancreatic ductal adenocarcinoma - Measurable disease - Life expectancy > 12 weeks - Normal organ and marrow function - Fasting blood glucose </= 150 mg/dL - Able to swallow pills Exclusion Criteria: - Prior chemotherapy or radiotherapy for treatment of pancreatic cancer - Receiving any other experimental agent - Known brain metastases - History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906 - Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea) - Use of enzyme-inducing anti-epileptic drugs - Diabetes mellitus which requires the use of exogenous insulin for glucose control - Major surgery within 4 weeks of the start of study treatment - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Use of strong or moderate CYP1A2 inhibitors/inducers - Pregnant or breast feeding - History of a different malignancy unless disease-free for at least 3 years - HIV positive |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Dana-Farber Cancer Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with adverse events as a measure of safety and tolerability | Phase I study to assess the safety, tolerability and maximally tolerated dose (MTD) of OSI-906 administered in combination with gemcitabine and erlotinib is patients with metastatic pancreatic ductal adenocarcinoma | 1 years | Yes |
| Primary | Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906 | Phase II trial to assess overall survival associated with OSI-906, gemcitabine and erlotinib compared with gemcitabine and erlotinib alone in patients with previous untreated metastatic pancreatic ductal adenocarcinoma | 2 years | No |
| Secondary | Progression-free survival among patients receiving gemcitabine + erlotinib vs. gemcitabine + erlotinib + OSI-906 | To assess progression-free survival associated with OSI-906, gemcitabine and erlotinib compared to gemcitabine and erlotinib alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma | 2 years | No |
| Secondary | Tumor response rate among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906 | To assess tumor response rate associated with OSI-906, gemcitabine and erlotinib compared to gemcitabine and erlotinib alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma | 2 years | No |