NCT00504998|CompletedPhase 1/2DMC
Safety/Efficacy Study of Rexin-G to Treat Pancreatic Cancer
Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer
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Sponsor study identifier
Secondary identifiers
interventional
20
1 country
3
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
June 2011
Actual (reported)The goal of the adaptive trial design is to determine the over-all safety of escalating doses of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 18, 2007
Actual (reported)July 20, 2007
Actual (reported)July 2010
Actual (reported)June 2011
Actual (reported)Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles.
24
To identify an objective tumor response to Rexin-G
24 months
Dose Level 1 of escalating doses of Rexin-G i.v.
Dose Level 2 of escalating doses of Rexin-G i.v.
Dose Level 3 of escalating doses of Rexin-G i.v.
Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Dosing Schedule: 1 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Epeius Clinical Research Unit
San Marino, California, 91108, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Bruckner Oncology
New York, New York, 10003, United States
Sant P Chawla, M.D.
Epeius Clinical Research Unit/Sarcoma Oncology Center
Howard W Bruckner, M.D.
Bruckner Oncology
20 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
Dose Level 4 of escalating doses of Rexin-G i.v.
Dose Level 5 of escalating doses of Rexin-G i.v.
Dosing Schedule: 2 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Dose Schedule: 3 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has less than Grade 1 or less toxicity.
Dosing Schedule: 4 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2010
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
June 10, 2011
Record last verified: 2010-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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