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OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

This study has been withdrawn prior to enrollment.
(Study was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600807
First Posted: May 17, 2012
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
August 8, 2011
May 17, 2012
June 26, 2013
Not Provided
Not Provided
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 years ]
    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
  • Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906 [ Time Frame: 2 years ]
    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
Same as current
Complete list of historical versions of study NCT01600807 on ClinicalTrials.gov Archive Site
  • Progression-free survival among patients receiving gemcitabine + erlotinib vs. gemcitabine + erlotinib + OSI-906 [ Time Frame: 2 years ]
    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
  • Tumor response rate among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906 [ Time Frame: 2 years ]
    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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer, Metastatic
  • Drug: Gemcitabine, Erlotinib, OSI-906
    Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID
    Other Names:
    • Gemzaar
    • Tarceva
  • Drug: Gemcitabine, Erlotinib
    Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD
    Other Names:
    • Gemzaar
    • Tarceva
  • Experimental: Gemcitabine, Erlotinib, OSI-906
    Experimental treatment arm
    Intervention: Drug: Gemcitabine, Erlotinib, OSI-906
  • Active Comparator: Gemcitabine, Erlotinib
    Standard treatment arm
    Intervention: Drug: Gemcitabine, Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01600807
11-148
Yes
Not Provided
Not Provided
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Brian Wolpin, MD, MPH Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP