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A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Adenocarcinoma

Thank you

Trial Information

A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma


Inclusion Criteria:



- Inoperable cancer of the pancreas.

- Blood cell counts and blood chemistries in or near normal range.

- Able to perform the activities of daily living.

- A projected life expectancy of at least 2 months.

- If female, neither pregnant nor nursing.

- Willing to use contraceptives to prevent pregnancy.

- No other serious illnesses.

- No other active malignancy.

- No serious infections.

- No current other drug therapy for the cancer or steroid therapy.

- Prior radiation is permitted as is chemotherapy given during radiation or to prevent
relapse after surgical removal of the disease.

Exclusion Criteria:

- Prior chemotherapy for metastatic disease.

- Brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximally tolerated dose (MTD)

Outcome Time Frame:

until MTD reached

Safety Issue:

Yes

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

AMP-004

NCT ID:

NCT00327327

Start Date:

February 2004

Completion Date:

October 2009

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location
Arizona Clinical Research Center Tucson, Arizona  85712
US Oncology Indiana Indianapolis, Indiana  46227
US Oncology Albany, New York Oncology Albany, New York  12208
US Oncology Orlando, Cancer Centers of FL Ocoee, Florida  34761
Univ of Michigan Ann Arbor, Michigan  48109
US Oncology Kettering Kettering, Ohio  45409
Fox Chase Cancer Ctr. Philadelphia, Pennsylvania  19111
US Oncology, Virginia Oncology Assoc Norfolk, Virginia  23502
US Oncology Northwest, Northwest Cancer Specialists Vancouver, Washington  98684