A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 1/26/2018 |
Start Date: | September 2013 |
End Date: | November 2017 |
A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up
to approximately 34 patients may be enrolled into the study.
up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up
to approximately 34 patients may be enrolled into the study.
Inclusion Criteria:
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented Stage IV ductal adenocarcinoma of the pancreas
- Availability of tumor tissue, either archival FFPE or obtained at study entry through
fresh biopsy
- ECOG performance status of 0 or 1
- Adequate hematologic and end-organ function
- Evaluable or measurable disease per RECIST v1.1
- For women of childbearing potential and men with partners of childbearing potential,
agreement to use two effective forms of contraception
Exclusion Criteria:
- Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
- Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
- Known hypersensitivity to any component of study treatments
- Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
We found this trial at
5
sites
Indianapolis, Indiana 46202
Principal Investigator: Safi Shahda, M.D.
Phone: 317-274-0972
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Jordan Berlin, MD
Phone: 800-811-8480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Aurora, Colorado 80045
Principal Investigator: Wells A Messersmith, MD, FACP
Phone: 303-724-0747
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Heinz-Josef Lenz, M.D., F.A.C.P.
Phone: (323) 865-3955
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Steven Cohen, MD
Phone: 215-728-3450
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