A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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