A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

This study has been completed.

Study NCT00637247 Information provided by AmpliMed Corporation

First Received on March 10, 2008. Last Updated on November 30, 2010 History of Changes

Results First Received: September 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Pancreatic Neoplasms
Interventions:	Drug: imexon in combination with gemcitabine Drug: imexon placebo + gemcitabine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was from April 2008 to May 2009. Enrollment occurred at 34 clinical centers in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Amplimexon (Imexon) + Gemcitabine	Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
Imexon Placebo + Gemcitabine	Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2

Participant Flow: Overall Study

	Amplimexon (Imexon) + Gemcitabine	Imexon Placebo + Gemcitabine
STARTED	72	70
COMPLETED	72	70
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Amplimexon (Imexon) + Gemcitabine	Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
Imexon Placebo + Gemcitabine	Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2

Baseline Measures

	Amplimexon (Imexon) + Gemcitabine	Imexon Placebo + Gemcitabine	Total
Number of Participants [units: participants]	72	70	142
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	34	31	65
>=65 years	38	39	77
Age [units: years] Mean ± Standard Deviation	66.1 ± 10.6	64.9 ± 11.1	65.5 ± 10.8
Gender [units: participants]
Female	31	31	62
Male	41	39	80
Region of Enrollment [units: participants]
United States	72	70	142

Outcome Measures

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1. Primary:

Overall Survival for the Intent to Treat Population [ Time Frame: up to 2 years ]

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2. Secondary:

Objective Response Rates of the Two Treatment Arms [ Time Frame: one year ]

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3. Secondary:

Progression Free Survival [ Time Frame: one year ]

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4. Primary:

To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms [ Time Frame: up to 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

5. Secondary:

One Year Survival [ Time Frame: one year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

6. Secondary:

To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS [ Time Frame: one year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

7. Secondary:

To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment [ Time Frame: one year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The manuscript or abstract shall be submitted at least (45) days prior to submission for publication to permit Sponsor to request removal of any Confidential Information and to protect its rights to any patentable inventions set forth therein. Upon Sponsor’s reasonable request, the investigator shall redact Sponsor’s Confidential Information from any such proposed publication or shall delay publication for up to 90 days to permit Sponsor to protect its proprietary Information.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Robert Dorr
Organization: AmpliMed Corporation
phone: 520-626-7892
e-mail: bdorr@azcc.arizona.edu

No publications provided

Responsible Party:	Evan Hersh/ Chief Medical Officer, AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00637247 History of Changes
Other Study ID Numbers:	AMP-019
Study First Received:	March 10, 2008
Results First Received:	September 17, 2010
Last Updated:	November 30, 2010
Health Authority:	United States: Food and Drug Administration