NCT00327327

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

5.7 years

First QC Date

May 17, 2006

Last Update Submit

September 14, 2010

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Determine maximally tolerated dose (MTD)

    until MTD reached

  • determine dose limiting toxicities.

    until MTD reached

Secondary Outcomes (3)

  • Changes in plasma thiol levels

    until MTD reached

  • pharmacokinetics

    until MTD reached

  • objective tumor responses.

    until MTD reached

Interventions

imexonDRUG

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

gemcitabineDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior chemotherapy for metastatic disease.
  • Brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

US Oncology Orlando, Cancer Centers of FL

Ocoee, Florida, 34761, United States

Location

US Oncology Indiana

Indianapolis, Indiana, 46227, United States

Location

Univ of Michigan

Ann Arbor, Michigan, 48109, United States

Location

US Oncology Albany, New York Oncology

Albany, New York, 12208, United States

Location

US Oncology Kettering

Kettering, Ohio, 45409, United States

Location

Fox Chase Cancer Ctr.

Philadelphia, Pennsylvania, 19111, United States

Location

US Oncology, Virginia Oncology Assoc

Norfolk, Virginia, 23502, United States

Location

US Oncology Northwest, Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

Related 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/s00280-009-1162-y. Epub 2009 Oct 24.

    PMID: 19855966RESULT

MeSH Terms

Interventions

4-imino-1,3-diazabicyclo(3.1.0)hexan-2-oneGemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mark Zalupski, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Steven Cohen, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

February 1, 2004

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations

US(9)