A Randomized Study Of Amplimexon (Imexon) With Gemcitabine In Pancreatic Cancer

Study Overview

A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

N/A

Pancreatic Neoplasms

DRUG: imexon in combination with gemcitabine
DRUG: imexon placebo + gemcitabine

AMP-019

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 2008-03-10	Results First Submitted 2010-09-17	Last Update Submitted that met QC Criteria 2019-03-11
First Submitted that Met QC Criteria 2008-03-10	Results First Submitted that Met QC Criteria 2010-11-29	Last Update Posted (ACTUAL) 2019-03-20
First Posted (ACTUAL) 2008-03-17	Results First Posted 2010-11-30	Last Verified 2019-03

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:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: imexon + gemcitabine imexon + gemcitabine	DRUG: imexon in combination with gemcitabine 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
ACTIVE_COMPARATOR: Placebo + gemcitabine Placebo in combination with gemcitabine	DRUG: imexon placebo + gemcitabine imexon placebo IV + 1000 mg/m^2 gemcitabine IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: imexon + gemcitabine

imexon + gemcitabine

DRUG: imexon in combination with gemcitabine

875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV

ACTIVE_COMPARATOR: Placebo + gemcitabine

Placebo in combination with gemcitabine

DRUG: imexon placebo + gemcitabine

imexon placebo IV + 1000 mg/m^2 gemcitabine IV

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival for the Intent to Treat Population	To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.	up to 2 years
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events	Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events	Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rates of the Two Treatment Arms	Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.	one year
Progression Free Survival	To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.	one year

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:

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Evan Hersh, MD, AmpliMed Corporation

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

Cohen SJ, Zalupski MM, Conkling P, Nugent F, Ma WW, Modiano M, Pascual R, Lee FC, Wong L, Hersh E. A Phase 2 Randomized, Double-Blind, Multicenter Trial of Imexon Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy-naive Pancreatic Adenocarcinoma. Am J Clin Oncol. 2018 Mar;41(3):230-235. doi: 10.1097/COC.0000000000000260.

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Resources

PatientS

Caregivers

Clinical Trial Record