Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.
A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.
Sponsor study identifier
interventional
8
2 countries
4
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)The purpose of the first part of the study is to evaluate the safety, tolerability, and pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin given to patients with advanced solid tumors, and to select a dose for further evaluation in the second part of the study. The purpose of the second part of the study is to determine the safety, tolerability, and exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
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 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 9, 2012
Actual (reported)July 17, 2012
Actual (reported)May 2013
Actual (reported)June 2013
Actual (reported)Dose limiting toxicities (DLT)(Part 1)
From time taking first dose of CO-1.01 (Cycle 1 Day 1) through last day of Cycle 1 (Cycle 1 Day 21), an expected average of 6 weeks.
Adverse events (Description of event in medical terminology, Intensity, Relationship to drug, Outcome, and/or Follow up )(Part 2)
From time of signing informed consent form through 28 days after last dose of CO-1.01, an expected average of 7 weeks
Clinical Laboratory Abnormalities (ANC, Platelets, Hemoglobin, AST/ALT, Bilirubin, Creatinine clearance)(Part 2)
For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8.
CO-1.01 administered over 30 minutes followed by 75 mg/ml Cisplatin over 2 hours (both intravenous) on C1D1. CO-1.01 administered intravenously over 30 minutes on C1D8.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
University College London Cancer Institute
London, London, W1T 4TJ, United Kingdom
The Beatson West
Glasgow, Scotland, G12 0YN, United Kingdom
8 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2012
First Posted
July 17, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
ECG Abnormalities (Part 2)
Screening (within 2 weeks of Cycle 1 Day 1)
PK parameters for CO-1.01 and its metabolites in plasma and urine (AUC, Cmax, Tmax, half life, kel, Vss, Cl, and MRT) (Part 1)
Cycle 1: Day 1, Day 8
Adverse events (Description of event in medical terminology, Intensity, Relationship to drug, Outcome, and/or Follow up )( (Part 1)
From time of signing informed consent form through 28 days after last dose of CO-1.01, an expected average of 7 weeks
Clinical Laboratory Abnormalities (ANC, Platelets, Hemoglobin, AST/ALT, Bilirubin, Creatinine clearance)(Part 1)
For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8.
ECG abnormalities (Part 1)
Screening (within 2 weeks of Cycle 1 Day 1)
Overall response rate (ORR)(Part 2)
Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
March 11, 2014
Record last verified: 2014-03
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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