A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin
This study is ongoing, but not recruiting participants.
Sponsor:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01641575
First received: July 9, 2012
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor Non-small-cell Lung Cancer Lung Cancer |
Drug: CO-1.01 and Cisplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Clovis Oncology, Inc.:
Primary Outcome Measures:
- Dose limiting toxicities (DLT)(Part 1) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- Adverse events (Description of event in medical terminology, Intensity, Relationship to drug, Outcome, and/or Follow up )(Part 2) [ Time Frame: From time of signing informed consent form through 28 days after last dose of CO-1.01, an expected average of 7 weeks ] [ Designated as safety issue: Yes ]
- Clinical Laboratory Abnormalities (ANC, Platelets, Hemoglobin, AST/ALT, Bilirubin, Creatinine clearance)(Part 2) [ Time Frame: For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8. ] [ Designated as safety issue: Yes ]
- ECG Abnormalities (Part 2) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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) [ Time Frame: Cycle 1: Day 1, Day 8 ] [ Designated as safety issue: No ]
- Adverse events (Description of event in medical terminology, Intensity, Relationship to drug, Outcome, and/or Follow up )( (Part 1) [ Time Frame: From time of signing informed consent form through 28 days after last dose of CO-1.01, an expected average of 7 weeks ] [ Designated as safety issue: Yes ]
- Clinical Laboratory Abnormalities (ANC, Platelets, Hemoglobin, AST/ALT, Bilirubin, Creatinine clearance)(Part 1) [ Time Frame: For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8. ] [ Designated as safety issue: Yes ]
- ECG abnormalities (Part 1) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1) ] [ Designated as safety issue: Yes ]
- Overall response rate (ORR)(Part 2) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter ] [ Designated as safety issue: No ]
- Duration of response (Part 2) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter ] [ Designated as safety issue: No ]
- Progression-free survival (PFS)(Part 2) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter ] [ Designated as safety issue: No ]
- Tumor hENT1 expression (Part 2) [ Time Frame: Screening (within 2 weeks of Cycle 1 Day 1) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CO-1.01 and Cisplatin |
Drug: CO-1.01 and Cisplatin
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.
Other Name: Gemcitabine elaidate
|
Detailed Description:
The chemotherapy doublet of cisplatin and gemcitabine is an effective regimen for solid tumors including NSCLC. Entry of gemcitabine into tumor cells has been shown to be dependent on specific membrane transporter proteins, particularly human equilibrative nucleoside transporter 1 (hENT1). Patients with low tumor hENT-1 expression may respond poorly to gemcitabine-containing chemotherapy. Gemcitabine elaidate (CO-1.01) is a fatty acid derivative of gemcitabine, and can enter cells in the absence of hENT1. CO-1.01 therefore, may overcome hENT1-mediated resistance to gemcitabine.
CO-1.01 is currently being evaluated as a single agent in a pivotal randomized trial in 360 patients with metastatic pancreatic adenocarcinoma. The appropriate dose of CO-1.01 when given as part of combination therapy with a platinum agent such as cisplatin is not yet known. The objectives of this study are to:
- determine the maximum tolerated dose (MTD) of CO-1.01 when combined with a fixed dose of cisplatin in patients with solid tumors
- select a recommended dose (RD) for dose expansion in patients with Stage IIIb/IV NSCLC
- explore clinical activity of CO-1.01 in patients with Stage IIIb/IV NSCLC
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641575
Locations
| United States, Florida | |
| Florida Cancer Specialists | |
| Sarasota, Florida, United States, 34232 | |
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| United Kingdom | |
| The Beatson West | |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| University College London Cancer Institute | |
| London, United Kingdom, W1T 4TJ | |
Sponsors and Collaborators
Clovis Oncology, Inc.
More Information
No publications provided
| Responsible Party: | Clovis Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT01641575 History of Changes |
| Other Study ID Numbers: | CO-101-011 |
| Study First Received: | July 9, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Clovis Oncology, Inc.:
|
CO-1.01 CO-101 gemcitabine elaidate hENT1 nucleoside equilibrative transporter |
solid tumor non-small-cell lung cancer NSCLC lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013