Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With 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. Identifier: NCT00625586
Recruitment Status : Terminated (Corporate decision)
First Posted : February 28, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Biological: RAV12 plus gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment was conducted by two cancer institutes between April and June 2008.

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

Reporting Groups
RAV12 Plus Gemcitabine RAV12 monoclonal antibody plus gemcitabine

Participant Flow:   Overall Study
    RAV12 Plus Gemcitabine
Adverse Event                1 

  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
RAV12 Plus Gemcitabine Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days

Baseline Measures
   RAV12 Plus Gemcitabine 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 61 [1] 
[1] Only 2 patients enrolled. Statistical analysis not performed.
[Units: Participants]
Female   2 
Male   0 
Region of Enrollment 
[Units: Participants]
United States   2 

  Outcome Measures

1.  Primary:   Proportion of Patients Alive at 8 Months   [ Time Frame: 8 months ]

2.  Secondary:   Proportion of Patients Alive at 12 Months   [ Time Frame: 12 months ]

3.  Secondary:   Partial Response and Complete Response Rates   [ Time Frame: 8 months ]

4.  Secondary:   Progression-free Survival   [ Time Frame: time to progression or death, up to 3 years ]

5.  Secondary:   Overall Survival   [ Time Frame: three years ]

6.  Secondary:   Adverse Events   [ Time Frame: any timeframe following study drug up to 3 years ]

7.  Secondary:   Cmax   [ Time Frame: 29 days ]

  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
Only 2 patients enrolled in the trial. Both were evaluable for safety and only one was evaluable for efficacy. No statistical analyses were performed.

  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: Sr. Director of Clinical Operations
Organization: MacroGenics, Inc.
phone: 650 624 2676

Responsible Party: MacroGenics Identifier: NCT00625586     History of Changes
Other Study ID Numbers: CDR0000587562
RAVENBIO-RV12-2007-003 ( Other Identifier: Macrogenics, Inc. )
First Submitted: February 26, 2008
First Posted: February 28, 2008
Results First Submitted: August 20, 2012
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012