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Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00625586
Recruitment Status : Terminated (Corporate decision)
First Posted : February 28, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
MacroGenics

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
Enrollment 2
Recruitment Details Patient recruitment was conducted by two cancer institutes between April and June 2008.
Pre-assignment Details  
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description RAV12 monoclonal antibody plus gemcitabine
Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description 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
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
61 [1]   (NA)
[1]
Only 2 patients enrolled. Statistical analysis not performed.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Proportion of Patients Alive at 8 Months
Hide Description [Not Specified]
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Proportion of Patients Alive at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Partial Response and Complete Response Rates
Hide Description Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame time to progression or death, up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Adverse Events
Hide Description Frequency of adverse events and serious adverse events
Time Frame any timeframe following study drug up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Cmax
Hide Description RAV12 and gemcitabine cmax
Time Frame 29 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAV12 Plus Gemcitabine
Hide Arm/Group Description 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
All-Cause Mortality
RAV12 Plus Gemcitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RAV12 Plus Gemcitabine
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Skin and subcutaneous tissue disorders   
Hospitalization with Grade 3 rash and leg pain; Grade 2 edema  1 [1]  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
Pt. hospitalized 2 days after second infusions. Events considered related to gemcitabine. Pt. discontinued from study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAV12 Plus Gemcitabine
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Cardiac disorders   
Pericardial effusion  1  1/2 (50.00%)  1
Gastrointestinal disorders   
Ascites  1  1/2 (50.00%)  1
Constipation  1  1/2 (50.00%)  1
Diarrhoea  1  1/2 (50.00%)  2
Dyspepsia  1  1/2 (50.00%)  1
Gingival bleeding  1  1/2 (50.00%)  1
Nausea  1  1/2 (50.00%)  3
Odynophagia  1  1/2 (50.00%)  1
Oral pain  1  1/2 (50.00%)  1
Stomatitis  1  1/2 (50.00%)  2
Vomiting  1  1/2 (50.00%)  2
General disorders   
Asthenia  1  1/2 (50.00%)  2
Chest discomfort  1  1/2 (50.00%)  1
Fatigue  1  2/2 (100.00%)  2
Influenza like illness  1  1/2 (50.00%)  1
Pain  1  1/2 (50.00%)  1
Oedema peripheral  1  2/2 (100.00%)  2
Infections and infestations   
Furuncle  1  1/2 (50.00%)  1
Injury, poisoning and procedural complications   
Joint sprain  1  1/2 (50.00%)  1
Investigations   
Haemoglobin decreased  1  2/2 (100.00%)  4
Neutrophil count decreased  1  1/2 (50.00%)  4
Platelet count decreased  1  2/2 (100.00%)  6
Urine colour abnormal  1  1/2 (50.00%)  1
Weight decreased  1  1/2 (50.00%)  2
White blood cell count decreased  1  1/2 (50.00%)  2
Metabolism and nutrition disorders   
Anorexia  1  1/2 (50.00%)  2
Hypokalaemia  1  1/2 (50.00%)  1
Hypophosphataemia  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/2 (50.00%)  1
Musculoskeletal pain  1  2/2 (100.00%)  2
Musculoskeletal stiffness  1  1/2 (50.00%)  1
Nervous system disorders   
Dizziness  1  1/2 (50.00%)  1
Dysgeusia  1  1/2 (50.00%)  1
Headache  1  1/2 (50.00%)  1
Psychiatric disorders   
Depression  1  1/2 (50.00%)  3
Renal and urinary disorders   
Dysuria  1  1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/2 (50.00%)  2
Pharyngolaryngeal pain  1  1/2 (50.00%)  1
Pleural effusion  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/2 (50.00%)  1
Dry skin  1  1/2 (50.00%)  1
Vascular disorders   
Hypotension  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Only 2 patients enrolled in the trial. Both were evaluable for safety and only one was evaluable for efficacy. No statistical analyses were performed.
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
ClinicalTrials.gov 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