Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer

NCT02050178 | Completed Phase 1

• 1 other identifier: 54F28-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 mg/kg.

Conditions

Pancreatic Cancer; Stage IV Pancreatic Cancer

Keywords

Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of OMP-54F28 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 gemcitabine in combination with weekly nab-paclitaxel (from Day 0 - 28)

  Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 28)

Secondary Outcomes (1)

• Pharmacokinetics (PK) of OMP-54F28 when administered in combination with nabpaclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer

  Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the gemcitabine infusion and before nabpaclitaxel infusion from Day 0 to treatment termination

Study Arms (1)

Drug: OMP-54F28, Nab-Paclitaxel and Gemcitabine

EXPERIMENTAL

Drug: OMP-54F28, Nab-Paclitaxel and Gemcitabine

Interventions

OMP-54F28, Nab-Paclitaxel and Gemcitabine DRUG

Drug: OMP-54F28, Nab-Paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age ≥18 years
• Histologically documented Stage IV ductal adenocarcinoma of the pancreas
• Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy
• Tumor tissue from fine needle aspiration is not acceptable.
• 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

You may not qualify if:

• 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
• Leptomeningeal disease as a manifestation of cancer
• Active infection requiring antibiotics
• Bisphosphonate therapy for symptomatic hypercalcemia
• Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Pregnancy, lactation, or breastfeeding
• Known HIV infection
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Concurrent use of therapeutic warfarin
• History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis
• New York Heart Association Classification III or IV

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (5)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Hospital Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

OMP-54F28; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Colin Weekes, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: November 1, 2013
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (5)