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Pancreatic Cancer
+1

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

Sponsored by OncoMed Pharmaceuticals, Inc.

About this trial

Last updated 5 years ago

Study ID

18R5-003

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 90 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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