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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637247
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : November 30, 2010
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
AmpliMed Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: imexon in combination with gemcitabine Drug: imexon placebo + gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)
Actual Study Start Date : April 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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
Other Name: Amplimexon, Gemzar

Active Comparator: Placebo + gemcitabine
Placebo in combination with gemcitabine
Drug: imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Other Name: Gemzar

Primary Outcome Measures :
  1. Overall Survival for the Intent to Treat Population [ Time Frame: up to 2 years ]
    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.

  2. To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events [ Time Frame: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months ]
    Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events

Secondary Outcome Measures :
  1. Objective Response Rates of the Two Treatment Arms [ Time Frame: one year ]
    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.

  2. Progression Free Survival [ Time Frame: one year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
  2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
  3. Age at least 18 years.
  4. ECOG performance status 0 or 1.
  5. No prior chemotherapy or radiation therapy.
  6. Projected life expectancy at least 2 months.
  7. If female, neither pregnant nor lactating.
  8. If of child bearing potential must agree to, and be able to use adequate contraception.
  9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
  10. No other concurrent active malignancy.
  11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
  12. Laboratory values within the following criteria:

    Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm^3 ANC greater than or equal 1,500/mm^3 Platelet count greater than or equal 100,000/mm^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)

  13. G6PD level greater than or equal lower limit of normal (LLN).
  14. Able to render informed consent and follow protocol requirements.

Exclusion Criteria:

  1. Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
  2. Age less than 18 years.
  3. ECOG performance status 2 or greater.
  4. Prior anticancer drug therapy for metastatic disease.
  5. Ascites.
  6. Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
  7. Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
  8. Life expectancy projected less than 2 months.
  9. Pregnancy or lactation.
  10. Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
  11. Laboratory parameters outside of specified ranges, (see above).
  12. Infection requiring parenteral antibiotics.
  13. NY Heart Association stage 3 or 4 heart disease.
  14. Unable to render informed consent.
  15. Failure to meet any of the eligibility criteria as outlined above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637247

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Sponsors and Collaborators
AmpliMed Corporation
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Study Director: Evan Hersh, MD AmpliMed Corporation
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center

S. J. Cohen, M. M. Zalupski, P. Conkling, F. W. Nugent, W. Ma, M. Modiano, R. A. Pascual, F. Lee, L. Wong, E. Hersh, J Clin Oncol 28:15s, 2010 (suppl; abstr 4076)

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Responsible Party: AmpliMed Corporation Identifier: NCT00637247     History of Changes
Other Study ID Numbers: AMP-019
First Posted: March 17, 2008    Key Record Dates
Results First Posted: November 30, 2010
Last Update Posted: March 20, 2019
Last Verified: March 2019
Keywords provided by AmpliMed Corporation:
pancreatic cancer
chemotherapy naive
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs