MedTrace Logo

Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

NCT01318642 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-08

Study results available
· View outcomes & findings →

Summary

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Conditions

  • Adenocarcinoma of the Pancreas
  • Locally Advanced
  • Unresectable

Interventions

DRUG

Gemcitabine

Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.

DRUG

AMG 479

Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.

DRUG

Placebo

Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle

Sponsors & Collaborators

  • NantBioScience, Inc.

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-11-27
Completion
2012-12-03

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318642 on ClinicalTrials.gov