A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

NCT01124786 | Completed Phase 2 Results DMC

• 1 other identifier: CO-101-001
• Study Type: interventional
• Target: 367
• Locations: 15 countries
• Sites: 95

Brief 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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

cancer; metastatic; pancreatic; pancreas; adenocarcinoma; gemcitabine; human equilibrative nucleoside transporter-1 (hENT1); CO-1.01; CO-101; CO101; Stage 4; Stage IV

Outcome Measures

Primary Outcomes (1)

• Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression

  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

  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

  Every 8 weeks

• Cancer Antigen (CA)19-9 Response Rates

  Every 4 weeks, up to 1.5 years

• Drug Tolerability and Toxicity

  Every week, up to 1.5 years

• Change From Baseline in Pain Severity

  Every 4 weeks, up to 1.5 years

Study Arms (2)

CO-1.01

EXPERIMENTAL

Drug: CO-1.01

gemcitabine

ACTIVE COMPARATOR

Drug: Gemcitabine

Interventions

CO-1.01 DRUG

1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

CO-1.01

Gemcitabine DRUG

1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks

gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Clovis Oncology, Inc.: lead

Study Sites (95)

Arizona Center for Hematology Oncology

Glendale, Arizona, 85306, United States

Location

Wilshire Oncology Medical Group, Inc.

Corona, California, 92879, United States

Location

White Memorial Medical Center

Los Angeles, California, 90033, United States

Location

Cancer Care Institute

Los Angeles, California, 90036, United States

Location

Newport Cancer Care Medical

Newport Beach, California, 92660, United States

Location

Hematology Oncology Associates

Oakland, California, 94609, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Hartford Hospital Clinical Research

Hartford, Connecticut, 06102, United States

Location

Oncology Associates of Bridgeport

Trumbull, Connecticut, 06611, United States

Location

Annapolis Oncology Center

Annapolis, Maryland, 21401, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87109, United States

Location

Arena Oncology Associates, PC

Lake Success, New York, 11042, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Cancer Specialists of South Texas, P.A.

Corpus Christi, Texas, 78412, United States

Location

Valley Cancer Associates

Harlingen, Texas, 78550, United States

Location

South Texas Oncology and Hematology, PA

San Antonio, Texas, 78229, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Policlínica Privada Instituto de Medicina Nuclear

Buenos Aires, Bahia Blanca, B8000FJI, Argentina

Location

Instituto Especializado Alexander Fleming

Cuidad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Hospital de Gastroenterología

Loma Hermosa, Buenos Aires, B1657BHD, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, Córdoba Province, X5004FHP, Argentina

Location

ISIS Centro Especializado

Santa Fe, Santa Fe Province, S3000FFU, Argentina

Location

Newcastle Private Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, New South Wales, 2444, Australia

Location

Southern Medical Day Oncology Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Saint Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Border Medical Oncology, Murray Valley Private Hospital

Wodonga, Victoria, 3690, Australia

Location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier de Jolimont-Lobbes

Haine-Saint-Paul, 7100, Belgium

Location

Hospital Universitario

Brasília, Federal District, 70840, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, 60430-230, Brazil

Location

Instituto Nacional do Cancer

Rio de Janeiro, Rio de Janeiro, 20231, Brazil

Location

Irmandade da Santa

Porto Alegre, Rio Grande do Sul, 90020, Brazil

Location

Hospital São Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

CEPON-Centro de pesquisas Oncologicas

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Hospital do Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Fundacao Hospital

Jaú, São Paulo, 17210, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64109, France

Location

Hôpital Saint André, Service d'Oncologie Médicale

Bordeaux, 33000, France

Location

Clinique François Chénieux

Limoges, 87039, France

Location

Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

Montpellier, 34295, France

Location

Centre Regional de Lutte contre le Cancer Val d'Aurelle

Montpellier, 34298, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave-Roussy - Centre de Lutte Contre le Cancer

Villejuif, 94805, France

Location

Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München

München, Bavaria, 81377, Germany

Location

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Knappschaftskrankenhaus Bochum-Langendreer

Bochum, North Rhine-Westphalia, 44892, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07740, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Klinik der Otto-Von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I

Ulm, 89081, Germany

Location

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Instituto Oncologico Veneto, Oncologia Medica 1

Padua, Padova, 35128, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Ospedali Riuniti di Ancona

Torrette Di Ancona, 60020, Italy

Location

Centro Ricerche Cliniche di Verona

Verona, 37134, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Sørlandet sykehus HF

Kristiansand, 4604, Norway

Location

Oslo Universitetssykehus, Ullevål

Oslo, 0407, Norway

Location

Republic Clinical Oncology Center

Izhevsk, Udmurtiya Republic, 426067, Russia

Location

Regional Oncology Center

Irkutsk, 664035, Russia

Location

Clinical Oncology Center #1

Krasnodar, 350040, Russia

Location

Kursk Regional Oncology Center

Kursk, 305035, Russia

Location

Blokhin Cancer Research Center

Moscow, 115478, Russia

Location

Novosibirsk, City Clinical Hospital #1

Novosibirsk, 630047, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

Mechnikov St. Petersburg State Medical Academy

Saint Petersburg, 195067, Russia

Location

St. Petersburg City Oncology Center

Saint Petersburg, 197785, Russia

Location

Tambov Regional Oncology Center

Tambov, 392013, Russia

Location

Tula Regional Oncology Center

Tula, 300053, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, 150040, Russia

Location

Sverdlovsk Regional Oncology Center

Yekaterinburg, 620036, Russia

Location

Lanssjukhuset Ryhov

Jönköping, 551 85, Sweden

Location

Linköping University Hospital

Linköping, 581 85, Sweden

Location

Växjö Centrallasarettet

Vaxjo, 351 85, Sweden

Location

Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology

Dnipropetrovsk, 49102, Ukraine

Location

Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6

Donetsk, 83092, Ukraine

Location

"Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department

Kharkiv, 61070, Ukraine

Location

National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum

Kiev, 03022, Ukraine

Location

State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department

Lviv, 79031, Ukraine

Location

Mykolayiv Regional Oncology Center, Surgery Department #1

Mykolayiv, 54044, Ukraine

Location

Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department

Uzhhorod, 88014, Ukraine

Location

Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1

Zaporizhya, 69032, Ukraine

Location

Hammersmith Hospital

London, England, W12 0HS, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)

Glasgow, Scotland, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed. However, patient enrollment completed normally.

Results Point of Contact

• Title: VP Clinical Development
• Organization: Clovis Oncology, Inc.

clinicaltrialinfo@clovisoncology.com

415-409-5440

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 17, 2014
• Results First Posted: April 17, 2014

Record last verified: 2014-03

Locations

AU (6); GB (3); CA (1); BR (9); US (21); SE (3); AR (5); RU (13); BE (3); DE (8); NL (1); UA (8); IT (5); NO (2); FR (7)