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Clinical Trial VICCGI1370

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

Principal Investigator(s)

Jordan Berlin

Details

  • Protocol No. VICCGI1370
  • Open Date: 12/30/2013
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer To identify dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer To identify a recommended Phase 2 dose for vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
  • Disease Sites: Pancreatic
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Gemcitabine; Nab-paclitaxel; Vantictumab
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02005315
  • Secondary Protocol No: 18R5-003

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years to 90 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

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