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Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer, Metastatic

Thank you

Trial Information

Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas

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.

Inclusion Criteria:

- Metastatic pancreatic ductal adenocarcinoma

- Measurable disease

- Life expectancy > 12 weeks

- Normal organ and marrow function

- Fasting blood glucose
- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with adverse events as a measure of safety and tolerability

Outcome Description:

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

Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Brian Wolpin, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Cancer, Metastatic
  • Metastatic
  • Pancreas
  • Cancer
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Ductal, Breast



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617