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

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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.

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.

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
1211 Medical Center Dr
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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Aurora, CO
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Indianapolis, Indiana 46202
Principal Investigator: Safi Shahda, M.D.
Phone: 317-274-0972
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Indianapolis, IN
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1441 Eastlake Ave
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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Los Angeles, CA
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Philadelphia, Pennsylvania 19111
Principal Investigator: Steven Cohen, MD
Phone: 215-728-3450
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Philadelphia, PA
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