A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Pancreatic Cancer
Interventions
DRUG

Demcizumab

Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.

DRUG

Abraxane®

Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.

DRUG

Gemcitabine

Gemcitabine will be administered intravenously over 30 minutes initially at a dose of 1000 mg/m2 once a week for 3 weeks in a row, followed by a week of rest. If you develop side effects during this time period, your physician may decide to hold or reduce the dose of gemcitabine.

Trial Locations (6)

2050

Royal Prince Alfred Hospital, Camperdown

3128

Box Hill Hospital, Box Hill

Unknown

The Austin Hospital, Heidelberg

Christchurch Hospital, Christchurch

Waikato Hospital, Hamilton

START Madrid, Madrid

Sponsors
All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

OncoMed Pharmaceuticals, Inc.

INDUSTRY

NCT01189929 - A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer | Biotech Hunter | Biotech Hunter