Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327327
• Other study ID #: AMP-004
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2006
• Last updated: September 14, 2010
• Start date: February 2004
• Est. completion date: October 2009

Study information

• Verified date: September 2010
• Source: AmpliMed Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• imexon
30-60 minutes IV, days 1,8,15 every 28 days
• gemcitabine
30 minutes IV, days 1,8,15 every 28 days

Locations

Country	Name	City	State
United States	US Oncology Albany, New York Oncology	Albany	New York
United States	Univ of Michigan	Ann Arbor	Michigan
United States	US Oncology Indiana	Indianapolis	Indiana
United States	US Oncology Kettering	Kettering	Ohio
United States	US Oncology, Virginia Oncology Assoc	Norfolk	Virginia
United States	US Oncology Orlando, Cancer Centers of FL	Ocoee	Florida
United States	Fox Chase Cancer Ctr.	Philadelphia	Pennsylvania
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	US Oncology Northwest, Northwest Cancer Specialists	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AmpliMed Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maximally tolerated dose (MTD)		until MTD reached	Yes
Primary	determine dose limiting toxicities.		until MTD reached	Yes
Secondary	Changes in plasma thiol levels		until MTD reached	No
Secondary	pharmacokinetics		until MTD reached	No
Secondary	objective tumor responses.		until MTD reached	No