A Study Of Vantictumab (OMP-18R5) In Combination With Nab-Paclitaxel And Gemcitabine In Previously Untreated Stage IV Pancreatic Cancer

Study Overview

A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in 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.

Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: Vantictumab
DRUG: Nab-Paclitaxel
DRUG: Gemcitabine

18R5-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-12-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-09-07
First Submitted that Met QC Criteria 2013-12-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-09-09
First Posted (ACTUAL) 2013-12-09	Results First Posted N/A	Last Verified 2020-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Vanctictumab (OMP-18R5) Vantictumab will be administered by intravenous (IV) infusion.	DRUG: Vantictumab Administered intravenous (IV) infusion. 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. 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. DRUG: Nab-Paclitaxel Nab-Paclitaxel will be administered by intravenous (IV) infusion. DRUG: Gemcitabine Gemcitabine will be administered by intravenous (IV) infusion.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Vanctictumab (OMP-18R5)

Vantictumab will be administered by intravenous (IV) infusion.

DRUG: Vantictumab

Administered intravenous (IV) infusion.

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.

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.

DRUG: Nab-Paclitaxel

Nab-Paclitaxel will be administered by intravenous (IV) infusion.

DRUG: Gemcitabine

Gemcitabine will be administered by intravenous (IV) infusion.

Primary Outcome Measures	Measure Description	Time Frame
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer	The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel	Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer	Apparent half life, AUC, clearance, volume of distribution	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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Romnee Clark, MD, Indiana University Institutional Review Board (IRB)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record