Metastatic Pancreatic AdenocarcinomaPhase 2NCT01124786
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
A Phase 2 study testing CO-1.01 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Clovis Oncology, Inc. at 95 sites in 15 countries.
Trial summary
The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- CO-1.01 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 95 sitesin 15 countries
- Study dates
- May 2010to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
- Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H\&E stain) to ensure sufficient material is available for later hENT1 analysis.
- Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
- Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
- CT scan ≤30 days prior to randomization
- Performance Status (ECOG) 0 or 1.
Show all 10Show fewer
- Estimated life expectancy ≥ 12 weeks.
- Age ≥ 18 years.
- Adequate hematological and biological function.
- Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.
Who cannot join
- Prior palliative chemotherapy for pancreatic cancer.
- Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
- Symptomatic brain metastases.
- Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
- Concomitant treatment with prohibited medications.
- History of allergy to gemcitabine or eggs.
Show all 12Show fewer
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
- Any disorder that would hamper protocol compliance.
- Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
- Females who are pregnant or breastfeeding.
- Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
- Any other reason the investigator considers the patient should not participate in the study.
Trial locations and contacts
95 sites in 15 countries.
95 sites in 15 countries
United States21 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87109
Annapolis Oncology Center
Annapolis, Maryland, 21401
Bend Memorial Clinic
Bend, Oregon, 97701
Wilshire Oncology Medical Group, Inc.
Corona, California, 92879
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, 78412
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Arizona Center for Hematology Oncology
Glendale, Arizona, 85306
Cancer Center of the Carolinas
Greenville, South Carolina, 29605
Valley Cancer Associates
Harlingen, Texas, 78550
Hartford Hospital Clinical Research
Hartford, Connecticut, 06102
Arena Oncology Associates, PC
Lake Success, New York, 11042
White Memorial Medical Center
Los Angeles, California, 90033
Cancer Care Institute
Los Angeles, California, 90036
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Newport Cancer Care Medical
Newport Beach, California, 92660
Hematology Oncology Associates
Oakland, California, 94609
South Texas Oncology and Hematology, PA
San Antonio, Texas, 78229
Sharp Clinical Oncology Research
San Diego, California, 92123
Oncology Associates of Bridgeport
Trumbull, Connecticut, 06611
Russia13 sites
Regional Oncology Center
Irkutsk, 664035
Republic Clinical Oncology Center
Izhevsk, Udmurtiya Republic, 426067
Clinical Oncology Center #1
Krasnodar, 350040
Kursk Regional Oncology Center
Kursk, 305035
Blokhin Cancer Research Center
Moscow, 115478
Novosibirsk, City Clinical Hospital #1
Novosibirsk, 630047
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Mechnikov St. Petersburg State Medical Academy
Saint Petersburg, 195067
St. Petersburg City Oncology Center
Saint Petersburg, 197785
Tambov Regional Oncology Center
Tambov, 392013
Tula Regional Oncology Center
Tula, 300053
Regional Clinical Oncology Hospital
Yaroslavl, 150040
Sverdlovsk Regional Oncology Center
Yekaterinburg, 620036
Brazil9 sites
Hospital do Cancer de Barretos
Barretos, São Paulo, 14784-400
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, 60430-230
Hospital Universitario
Brasília, Federal District, 70840
CEPON-Centro de pesquisas Oncologicas
Florianópolis, Santa Catarina, 88034-000
Fundacao Hospital
Jaú, São Paulo, 17210
Irmandade da Santa
Porto Alegre, Rio Grande do Sul, 90020
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto Nacional do Cancer
Rio de Janeiro, Rio de Janeiro, 20231
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Germany8 sites
Charité Universitätsmedizin Berlin
Berlin, 13353
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, North Rhine-Westphalia, 44892
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Klinikum der Ernst-Moritz-Arndt-Universität
Greifswald, Mecklenburg-Vorpommern, 17475
Universitätsklinikum Jena
Jena, Thuringia, 07740
Klinik der Otto-Von-Guericke-Universität Magdeburg
Magdeburg, 39120
Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
München, Bavaria, 81377
Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
Ulm, 89081
Ukraine8 sites
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
Dnipropetrovsk, 49102
Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
Donetsk, 83092
"Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
Kharkiv, 61070
National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
Kiev, 03022
State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
Lviv, 79031
Mykolayiv Regional Oncology Center, Surgery Department #1
Mykolayiv, 54044
Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
Uzhhorod, 88014
Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1
Zaporizhya, 69032
France7 sites
Centre Hospitalier de la Cote Basque
Bayonne, 64109
Hôpital Saint André, Service d'Oncologie Médicale
Bordeaux, 33000
Clinique François Chénieux
Limoges, 87039
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
Montpellier, 34295
Centre Regional de Lutte contre le Cancer Val d'Aurelle
Montpellier, 34298
Centre René Gauducheau
Saint-Herblain, 44805
Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
Villejuif, 94805
Australia6 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Saint Vincent's Hospital
Fitzroy, Victoria, 3065
Newcastle Private Hospital
New Lambton Heights, New South Wales, 2305
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Border Medical Oncology, Murray Valley Private Hospital
Wodonga, Victoria, 3690
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, 2500
Argentina5 sites
Policlínica Privada Instituto de Medicina Nuclear
Buenos Aires, Bahia Blanca, B8000FJI
Clínica Universitaria Reina Fabiola
Córdoba, Córdoba Province, X5004FHP
Instituto Especializado Alexander Fleming
Cuidad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Hospital de Gastroenterología
Loma Hermosa, Buenos Aires, B1657BHD
ISIS Centro Especializado
Santa Fe, Santa Fe Province, S3000FFU
Italy5 sites
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
Fondazione San Raffaele del Monte Tabor
Milan, 20132
Instituto Oncologico Veneto, Oncologia Medica 1
Padova, Padova, 35128
Ospedali Riuniti di Ancona
Torrette Di Ancona, 60020
Centro Ricerche Cliniche di Verona
Verona, 37134
Belgium3 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650
Centre Hospitalier de Jolimont-Lobbes
Haine-Saint-Paul, 7100
Sweden3 sites
Lanssjukhuset Ryhov
Jönköping, 551 85
Linköping University Hospital
Linköping, 581 85
Växjö Centrallasarettet
Vaxjo, 351 85
United Kingdom3 sites
Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
Glasgow, Scotland, G12 0YN
Hammersmith Hospital
London, England, W12 0HS
Christie Hospital
Manchester, England, M20 4BX
Norway2 sites
Sørlandet sykehus HF
Kristiansand, 4604
Oslo Universitetssykehus, Ullevål
Oslo, 0407
Netherlands1 site
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, 1081 HV
About this study
Official title: A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
Read the detailed description
Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.
The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- CO-1.01, Gemcitabine
- Keywords
- cancer, metastatic, pancreatic, pancreas, adenocarcinoma, gemcitabine, human equilibrative nucleoside transporter-1 (hENT1), CO-1.01, CO-101, CO101, Stage 4, Stage IV
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-1.01Drug
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
GemcitabineDrug
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CO-1.01 | Experimental | Not described Receives: Drug: CO-1.01 |
| gemcitabine | Active comparator | Not described Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Measured: Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Secondary outcomes (7)
Overall Survival in All Patients and Patients With hENT1 Expression
Measured: Monthly follow up after treatment discontinuation until death, up to 1.5 years
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Measured: Every 8 weeks
Cancer Antigen (CA)19-9 Response Rates
Measured: Every 4 weeks, up to 1.5 years
Drug Tolerability and Toxicity
Measured: Every week, up to 1.5 years
Change From Baseline in Pain Severity
Measured: Every 4 weeks, up to 1.5 years
Change From Baseline in Health Status
Measured: Every 4 weeks, up to 1.5 years
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Measured: 30 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 367 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
- NCT01124786
- Sponsor's protocol ID
- CO-101-001
- Status last verified
- Mar 2014
- First submitted
- 12 May 2010
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01124786
- Acronym / sponsor ID
- CO-101-001
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- cancer, metastatic, pancreatic, pancreas, adenocarcinoma, gemcitabine, human equilibrative nucleoside transporter-1 (hENT1), CO-1.01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Clovis Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 17 Apr 2014
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 this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
Detailed description
Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.
The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO-1.01 | Experimental | Drug: CO-1.01 |
| gemcitabine | Active comparator | Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
- Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H\&E stain) to ensure sufficient material is available for later hENT1 analysis.
- Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
- Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
- CT scan ≤30 days prior to randomization
Key exclusion criteria (12 listed)
- Prior palliative chemotherapy for pancreatic cancer.
- Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
- Symptomatic brain metastases.
- Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
- Concomitant treatment with prohibited medications.
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-1.011250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks | Drug | CO-1.01 |
| Gemcitabine1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks | Drug | gemcitabine |
Primary outcome
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Time frame: Monthly follow up after treatment discontinuation until death, up to 1.5 years.
7 secondary outcomes
Overall Survival in All Patients and Patients With hENT1 Expression
Time frame: Monthly follow up after treatment discontinuation until death, up to 1.5 years
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Time frame: Every 8 weeks
Cancer Antigen (CA)19-9 Response Rates
Time frame: Every 4 weeks, up to 1.5 years
Drug Tolerability and Toxicity
Time frame: Every week, up to 1.5 years
Change From Baseline in Pain Severity
Time frame: Every 4 weeks, up to 1.5 years
Change From Baseline in Health Status
Time frame: Every 4 weeks, up to 1.5 years
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Time frame: 30 days after first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
95 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CO-1.01 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Clovis Oncology, Inc. at 95 sites in 15 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 10 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: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Russia, Brazil, Germany, Ukraine and 10 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression (time frame: Monthly follow up after treatment discontinuation until death, up to 1.5 years.). 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 17 Apr 2014.