A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02005315 |
Recruitment Status :
Completed
First Posted : December 9, 2013
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer Stage IV Pancreatic Cancer | Drug: Vantictumab Drug: Nab-Paclitaxel Drug: Gemcitabine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 2013 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
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Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Name: OMP-18R5 Drug: Nab-Paclitaxel Nab-Paclitaxel will be administered by intravenous (IV) infusion. Drug: Gemcitabine Gemcitabine will be administered by intravenous (IV) infusion. |
Experimental: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
|
Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Name: OMP-18R5 Drug: Nab-Paclitaxel Nab-Paclitaxel will be administered by intravenous (IV) infusion. Drug: Gemcitabine Gemcitabine will be administered by intravenous (IV) infusion. |
Experimental: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
|
Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Name: OMP-18R5 Drug: Nab-Paclitaxel Nab-Paclitaxel will be administered by intravenous (IV) infusion. Drug: Gemcitabine Gemcitabine will be administered by intravenous (IV) infusion. |
- Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) ]The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel
- Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer [ Time Frame: Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle. ]Apparent half life, AUC, clearance, volume of distribution

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005315
United States, California | |
USC/Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 | |
United States, Colorado | |
University of Colorado Hospital Anschutz Cancer Pavillion | |
Aurora, Colorado, United States, 80045 | |
United States, Indiana | |
Indiana University Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Romnee Clark, MD | Indiana University Institutional Review Board (IRB) |
Responsible Party: | OncoMed Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02005315 |
Other Study ID Numbers: |
18R5-003 |
First Posted: | December 9, 2013 Key Record Dates |
Last Update Posted: | September 9, 2020 |
Last Verified: | September 2020 |
Pancreatic Cancer Stage IV Pancreatic Cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |