Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma - Full Text View

Sponsored by:	AmpliMed Corporation
Information provided by:	AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00327327

Purpose

AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer.

The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.

Condition	Intervention	Phase
Pancreatic Adenocarcinoma	Drug: imexon Drug: gemcitabine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:

Determine maximally tolerated dose (MTD) [ Time Frame: until MTD reached ] [ Designated as safety issue: Yes ]
determine dose limiting toxicities. [ Time Frame: until MTD reached ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in plasma thiol levels [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]
pharmacokinetics [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]
objective tumor responses. [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2004
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

30-60 minutes IV, days 1,8,15 every 28 days

30 minutes IV, days 1,8,15 every 28 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327327

Locations

United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, Florida
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States, 34761
United States, Indiana
US Oncology Indiana
Indianapolis, Indiana, United States, 46227
United States, Michigan
Univ of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
US Oncology Albany, New York Oncology
Albany, New York, United States, 12208
United States, Ohio
US Oncology Kettering
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Fox Chase Cancer Ctr.
Philadelphia, Pennsylvania, United States, 19111
United States, Virginia
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States, 23502
United States, Washington
US Oncology Northwest, Northwest Cancer Specialists
Vancouver, Washington, United States, 98684

Sponsors and Collaborators

AmpliMed Corporation

Investigators

Principal Investigator:	Mark Zalupski, MD	University of Michigan
Principal Investigator:	Steven Cohen, MD	Fox Chase Cancer Center

More Information

No publications provided

Responsible Party:	AmpliMed Corporation ( Evan Hersh, VP Medical Affairs )
Study ID Numbers:	AMP-004
Study First Received:	May 17, 2006
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00327327 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Radiation-Sensitizing Agents
Immunologic Factors
Gemcitabine

Adenocarcinoma
Immunosuppressive Agents
Antiviral Agents
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009