Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-03

Brief Summary

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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.

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Detailed Description

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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

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Adenocarcinoma of the Pancreas Locally Advanced Unresectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type DRUG

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

Interventions

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Gemcitabine

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

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Gemzar gemcitabine = Gemzar

Eligibility Criteria

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Inclusion Criteria

* Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
* Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women \>/= 18 years of age
* Adequate organ function

Exclusion Criteria

* Early (stage I) or metastatic (stage IV) disease
* Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
* External biliary drain
* Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
* Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No