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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)

Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms

Thank you

Trial Information

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)

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

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival for the Intent to Treat Population

Outcome Description:

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.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Evan Hersh, MD

Investigator Role:

Study Director

Investigator Affiliation:

AmpliMed Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

June 2010

Related Keywords:

  • Pancreatic Neoplasms
  • pancreatic cancer
  • metastatic
  • chemotherapy naive
  • Neoplasms
  • Pancreatic Neoplasms



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