Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01124786




Registration number
NCT01124786
Ethics application status
Date submitted
12/05/2010
Date registered
17/05/2010
Date last updated
17/04/2014

Titles & IDs
Public title
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
Scientific 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
Secondary ID [1] 0 0
CO-101-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CO-1.01
Treatment: Drugs - Gemcitabine

Experimental: CO-1.01 -

Active comparator: gemcitabine -


Treatment: Drugs: CO-1.01
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

Treatment: Drugs: Gemcitabine
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Timepoint [1] 0 0
Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Secondary outcome [1] 0 0
Overall Survival in All Patients and Patients With hENT1 Expression
Timepoint [1] 0 0
Monthly follow up after treatment discontinuation until death, up to 1.5 years
Secondary outcome [2] 0 0
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Timepoint [2] 0 0
Every 8 weeks
Secondary outcome [3] 0 0
Cancer Antigen (CA)19-9 Response Rates
Timepoint [3] 0 0
Every 4 weeks, up to 1.5 years
Secondary outcome [4] 0 0
Drug Tolerability and Toxicity
Timepoint [4] 0 0
Every week, up to 1.5 years
Secondary outcome [5] 0 0
Change From Baseline in Pain Severity
Timepoint [5] 0 0
Every 4 weeks, up to 1.5 years
Secondary outcome [6] 0 0
Change From Baseline in Health Status
Timepoint [6] 0 0
Every 4 weeks, up to 1.5 years
Secondary outcome [7] 0 0
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Timepoint [7] 0 0
30 days after first dose

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
367
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 0 0
Southern Medical Day Oncology Care Centre - Wollongong
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Saint Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
Border Medical Oncology, Murray Valley Private Hospital - Wodonga
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Maryland
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Minnesota
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New Jersey
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New Mexico
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New York
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Oregon
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South Carolina
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Texas
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Wisconsin
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Argentina
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Bahia Blanca
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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Santa Fe
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Haine-Saint-Paul
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Brazil
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Distrito Federal
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Brazil
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Minas Gerais
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Brazil
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Rio Grande do Sul
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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France
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Bayonne Cedex
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France
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Bordeaux
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France
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Limoges Cedex
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France
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Montpellier Cedex 5
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France
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Montpellier
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France
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Saint Herblain cedex
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France
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Villejuif Cedex
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Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Nordrhein-Westfalen
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Germany
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Thueringen
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Germany
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Berlin
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Dresden
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Germany
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Magdeburg
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Germany
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Ulm
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Italy
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Emilia-Romagna
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Italy
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Milano
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Italy
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Padova
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Italy
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Torrette di Ancona
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Italy
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Verona
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Netherlands
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Noord-Holland
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Norway
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Kristiansand
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Norway
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Oslo
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Russian Federation
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Republic of Udmurtia
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Russian Federation
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Ekaterinburg
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Russian Federation
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Irkutsk
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Russian Federation
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Krasnodar
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tambov
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Russian Federation
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Tula
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Russian Federation
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Yaroslavl
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Sweden
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Jonkoping
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Sweden
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Linköping
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Sweden
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Växjö
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Ukraine
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Dnipropetrovsk
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Donetsk
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Kharkiv
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Kiev
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Ukraine
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Lviv
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Ukraine
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Mykolayiv
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Ukraine
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Uzhorod
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Ukraine
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Zaporizhya
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United Kingdom
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England
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United Kingdom
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Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clovis Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01124786