Solid TumorPhase 1NCT01641575
A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin
A Phase 1 study testing CO-1.01 and Cisplatin in people with Solid Tumor and Non-small-cell Lung Cancer, run by Clovis Oncology, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Non-small-cell Lung Cancer, Lung Cancer
- What is being tested?
- CO-1.01 and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Tennessee Oncology
Nashville, Tennessee, 37203
Florida Cancer Specialists
Sarasota, Florida, 34232
United Kingdom2 sites
The Beatson West
Glasgow, Scotland, G12 0YN
University College London Cancer Institute
London, London, W1T 4TJ
About this study
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.
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).
Read the 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
- Conditions
- Solid Tumor, Non-small-cell Lung Cancer, Lung Cancer
- Being tested
- CO-1.01 and Cisplatin
- Keywords
- CO-1.01, CO-101, gemcitabine elaidate, hENT1, nucleoside equilibrative transporter, solid tumor, non-small-cell lung cancer, NSCLC, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-1.01 and CisplatinDrug
Also called Gemcitabine elaidate
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.
| Study group | Role | What they receive |
|---|---|---|
| CO-1.01 and Cisplatin | Experimental | Not described Receives: Drug: CO-1.01 and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLT)(Part 1)
Measured: 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)
Measured: 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)
Measured: For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8.
ECG Abnormalities (Part 2)
Measured: Screening (within 2 weeks of Cycle 1 Day 1)
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: For Cycle 1: Day 1, Day 8, Day 15. For subsequent cycles: Day 1, Day 8.
ECG abnormalities (Part 1)
Measured: Screening (within 2 weeks of Cycle 1 Day 1)
Overall response rate (ORR)(Part 2)
Measured: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter
Duration of response (Part 2)
Measured: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter
Progression-free survival (PFS)(Part 2)
Measured: Screening (within 2 weeks of Cycle 1 Day 1); prior to start of cycles 3,5,7; every 3 cycles thereafter
Tumor hENT1 expression (Part 2)
Measured: Screening (within 2 weeks of Cycle 1 Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clovis Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641575
- Sponsor's protocol ID
- CO-101-011
- Status last verified
- Mar 2014
- First submitted
- 9 Jul 2012
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01641575
- Acronym / sponsor ID
- CO-101-011
- Conditions
- Solid Tumor, Non-small-cell Lung Cancer, Lung Cancer
- Keywords
- CO-1.01, CO-101, gemcitabine elaidate, hENT1, nucleoside equilibrative transporter, solid tumor, non-small-cell lung cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clovis Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO-1.01 and Cisplatin | Experimental | Drug: CO-1.01 and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-1.01 and CisplatinAlso: Gemcitabine elaidateCO-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. | Drug | CO-1.01 and Cisplatin |
Primary outcome
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.
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
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.
ECG Abnormalities (Part 2)
Time frame: Screening (within 2 weeks of Cycle 1 Day 1)
8 secondary outcomes
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
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
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.
ECG abnormalities (Part 1)
Time frame: Screening (within 2 weeks of Cycle 1 Day 1)
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
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
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
Tumor hENT1 expression (Part 2)
Time frame: Screening (within 2 weeks of Cycle 1 Day 1)
Results and safety
The study was stopped early (reason given: Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CO-1.01 and Cisplatin in people with Solid Tumor and Non-small-cell Lung Cancer, run by Clovis Oncology, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.