Ganitumab In Locally Advanced Unresectable Adenocarcinoma Of The Pancreas

Study Overview

Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

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.

Adenocarcinoma of the Pancreas
Locally Advanced
Unresectable

DRUG: Gemcitabine
DRUG: AMG 479
DRUG: Placebo

20080261
2010-023978-39 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-03-17	Results First Submitted 2024-04-18	Last Update Submitted that met QC Criteria 2024-11-07
First Submitted that Met QC Criteria 2011-03-17	Results First Submitted that Met QC Criteria 2024-11-07	Last Update Posted (ACTUAL) 2024-11-08
First Posted (ACTUAL) 2011-03-18	Results First Posted 2024-11-08	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Placebo + Gemcitabine Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle	DRUG: Gemcitabine Gemcitabine on days 1, 8, and 15, followed by placebo 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
EXPERIMENTAL: AMG 479 20 mg/kg + Gemcitabine ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.	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.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Placebo + Gemcitabine

Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle

DRUG: Gemcitabine

Gemcitabine on days 1, 8, and 15, followed by placebo 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

EXPERIMENTAL: AMG 479 20 mg/kg + Gemcitabine

ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.

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.

Primary Outcome Measures	Measure Description	Time Frame
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.	The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.	From randomization to the date of either disease progression or death, up to 181 days progression or death

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival	OS - time from study day 1 to death (by any cause)	Up to 181 days
Number of Participants With Adverse Events	Measured via CTCAE v3.0	Up to 4 months
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate	PFS rates - subjects with disease progression (PD) or death at the timepoint; OS rates - subjects alive at the timepoint; ORR - tumor response assessment of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST); DCR - subjects with PR, CR, or SD Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed	Up to 181 days
Duration of Response	DOR - time from the first observation of an objective response (subjects with CR or PR) to the time of PD or death; Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed	Up to 181 days
Number of Participants With Anti-AMG 479 Antibodies	post-dose anti-AMG 479 antibody positive rate	Up to 181 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: MD, Amgen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record