A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005315
• Other study ID #: 18R5-003
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: November 2017

Study information

• Verified date: September 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Stage IV Pancreatic Cancer

Intervention

Drug:
• Vantictumab
Administered intravenous (IV) infusion.
• Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
• Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.

Locations

Country	Name	City	State
United States	University of Colorado Hospital Anschutz Cancer Pavillion	Aurora	Colorado
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.