A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin
Stopped early · Phase 1
Conditions studied: Solid Tumor, Non-small-cell Lung Cancer, Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT01641575
- Run by
- Clovis Oncology, Inc.
- People needed
- 8
- Starts
- 2012-07-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2014-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Understand and sign institutional review board/independent ethics committee-approved informed consent form (ICF) prior to any study-specific evaluation
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 1
- ≥ 18 years at the time ICF is signed
- Adequate hematological and biological function
- Histologically or cytologically confirmed solid tumor malignancy (Part 1 only)
- Histologically or cytologically confirmed stage IIIb/IV NSCLC (Part 2 only)
You may not qualify if…
- Symptomatic central nervous system metastases
- Concomitant treatment with prohibited medications, e.g. other chemotherapy, radiation, hormonal treatment (excepting corticosteroids), or immunotherapy ≤ 14 days prior to CO-1.01 treatment
- Treatment with a previous regimen of CO-1.01
- Participation in another therapeutic clinical study within 14 days of enrollment or during this clinical study
- Surgical procedures ≤ 14 days prior to CO-1.01 administration
- History of allergy to gemcitabine, gemcitabine elaidate or eggs
- Known allergic/hypersensitivity reaction to cisplatin, other platinum agent, or platinum containing compounds
- Peripheral neuropathy ≥ Grade 1
- Females who are pregnant or breastfeeding
- Refusal to use adequate contraception for fertile patients
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- Any other reason the investigator considers the patient should not participate in the study
Where it is running
- Florida Cancer Specialists — Sarasota, Florida, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- University College London Cancer Institute — London, London, United Kingdom
- The Beatson West — Glasgow, Scotland, United Kingdom
Full record on ClinicalTrials.gov
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