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BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreatic Cancer

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.
ClinicalTrials.gov Identifier: NCT00447122
Recruitment Status : Terminated
First Posted : March 14, 2007
Results First Posted : May 19, 2014
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Cancer
Intervention: Drug: gemcitabine and Lapatinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
31 patients were enrolled, 29 were evaluable

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lapatinib and Gemcitabine lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression

Participant Flow:   Overall Study
    Lapatinib and Gemcitabine
STARTED   31 
COMPLETED   29 [1] 
NOT COMPLETED   2 
[1] 29 evaluable thus 29 represented in efficacy and safety portion



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  41.9% 
>=65 years      18  58.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  41.9% 
Male      18  58.1% 
Region of Enrollment 
[Units: Participants]
 
United States   31 


  Outcome Measures

1.  Primary:   Number of Patients Who Survived at 4 Months: Overall Survival   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard Safran, MD
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu



Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT00447122     History of Changes
Other Study ID Numbers: BrUOG-PA-209
First Submitted: March 12, 2007
First Posted: March 14, 2007
Results First Submitted: May 21, 2013
Results First Posted: May 19, 2014
Last Update Posted: April 27, 2018