Phase 2
N=204
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
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02289898 ↗Enrolled (actual)
204
Serious AEs
60.3%
Results posted
Aug 2018
Primary outcome: Primary: Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms — 38; 70; 5; 12 Participants — p==0.7158
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Demcizumab (Drug); Abraxane® (Drug); gemcitabine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- OncoMed Pharmaceuticals, Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms |
38; 70; 5; 12; 3; 7 | =0.7158 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Availability of formalin-fixed paraffin-embedded (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.
- Age ≥21 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
- Adequate organ and marrow function
- Signed Informed Consent Form
- For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria
- Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
- 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.
- Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Subjects with Grade >2 peripheral neuropathy
- Subjects with clinically significant ascites
- 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
- 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
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
Data sourced from ClinicalTrials.gov (NCT02289898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.