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

OncoMed Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Stage IV Pancreatic Cancer; Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Vantictumab; Drug: Nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005315

18R5-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Vanctictumab (OMP-18R5)

Experimental group

Description:

Vantictumab will be administered by intravenous (IV) infusion.

Treatment:

Drug: Nab-Paclitaxel

Drug: Gemcitabine

Drug: Vantictumab

Nab-Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Nab-Paclitaxel

Drug: Gemcitabine

Drug: Vantictumab

Gemcitabine

Experimental group

Description:

Gemcitabine will be administered by intravenous (IV) infusion.

Treatment:

Drug: Nab-Paclitaxel

Drug: Gemcitabine

Drug: Vantictumab