Safety Study of Imexon Plus Gemcitabine in Untreated Panc... | NCT00327327

Studies
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

NCT00327327

Sponsor

AmpliMed Corporation

Status

Completed

Last Update Posted

Sep 15, 2010Estimated

Enrollment

105Actual

Phase

Phase 1

Conditions

Pancreatic Adenocarcinoma

Interventions

imexon
gemcitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 17, 2006

First Submission Date that Met QC Criteria

May 17, 2006

First Posted Date

May 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2010

Last Update Posted Date

Sep 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
imexon	Drug	30-60 minutes IV, days 1,8,15 every 28 days
gemcitabine	Drug	30 minutes IV, days 1,8,15 every 28 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine maximally tolerated dose (MTD)		until MTD reached
determine dose limiting toxicities.		until MTD reached

Secondary Outcomes

Measure	Description	Time Frame
Changes in plasma thiol levels		until MTD reached
pharmacokinetics		until MTD reached
objective tumor responses.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Zalupski, MD	University of Michigan	Principal Investigator
Steven Cohen, MD	Fox Chase Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Clinical Research Center		Tucson	Arizona	85715	United States
US Oncology Orlando, Cancer Centers of FL

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19855966	Result	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.

ID	Term
C014919	4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one
D000093542	Gemcitabine

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides