Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments demcizumab, abraxane®, gemcitabine, placebo
Phase phase 2
Target DLL4
Sponsor OncoMed Pharmaceuticals, Inc.
Collaborator Celgene Corporation
Start date April 2015
End date December 2016
Trial size 207 participants
Trial identifier NCT02289898, M18-006

Summary

This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.

The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.

United States California, Iowa, Kansas, New Hampshire, Ohio, Pennsylvania, and Utah
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
demcizumab
administered intravenously
abraxane®
administered intravenously
gemcitabine
administered intravenously
placebo
(Experimental)
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
demcizumab
administered intravenously
abraxane®
administered intravenously
gemcitabine
administered intravenously
(Experimental)
Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression
demcizumab
administered intravenously
abraxane®
administered intravenously
gemcitabine
administered intravenously

Primary Outcomes

Measure
Investigator-assessed median progression-free survival (PFS)
time frame: Assessed at baseline and every 8 weeks, from randomization until death or disease progression, up to 27 months

Secondary Outcomes

Measure
Investigator-assessed RECIST v1.1 response rate
time frame: Assessed at baseline and every 8 weeks up to 27 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: 1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed. 2. Availability of FFPE tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization. 3. Age ≥21 years 4. ECOG performance status 0 or 1 5. Measurable disease per RECIST v1.1 5. Adequate organ and marrow function 6. Signed Informed Consent Form 7. For women of childbearing potential, agreement to use two effective forms of contraception Exclusion Criteria: 1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies. 2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. 3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease 4. Subjects with Grade >2 peripheral neuropathy 5. Subjects with clinically significant ascites 6. Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent 7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months 8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy 9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease 10. Pregnant women or nursing women 11. Subjects with known HIV infection 12. Known bleeding disorder or coagulopathy

Additional Information

Official title A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by OncoMed Pharmaceuticals, Inc..