A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
2 other identifiers
interventional
207
19 countries
71
Brief Summary
This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Jun 2008
Longer than P75 for phase_2 pancreatic-cancer
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
April 26, 2016
CompletedJune 17, 2016
May 1, 2016
2.5 years
April 30, 2008
March 24, 2016
May 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.
From the time of randomization until progression of disease or death (up to 30 months)
Secondary Outcomes (4)
Percentage of Participants With Best Overall Response Rate
From the time of randomization until progression of disease or death (up to 30 months)
Percentage of Participants With Disease Control Rate (DCR)
Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Overall Survival
From the time of randomization until or death (up to 30 months)
Number of Participants With Adverse Events (AEs)
Up to 28 days after discontinuation of study drug (up to 30 months)
Study Arms (2)
Erlotinib
EXPERIMENTALParticipants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Placebo
PLACEBO COMPARATORParticipants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
- measurable disease according to RECIST;
- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
- ECOG performance status of 0-2.
You may not qualify if:
- local or locally advanced-resectable pancreatic cancer;
- any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- major surgery within 2 weeks prior to randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Unknown Facility
Kogarah, New South Wales, 2217, Australia
Unknown Facility
St Leonards, New South Wales, 2065, Australia
Unknown Facility
Sydney, New South Wales, 2076, Australia
Unknown Facility
Box Hill, Victoria, 3128, Australia
Unknown Facility
Salvador, Bahia, Estado de Bahia, 40170-380, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 30110-0090, Brazil
Unknown Facility
Curitiba, Paraná, 81520-060, Brazil
Unknown Facility
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Unknown Facility
Jaú, São Paulo, 17210-080, Brazil
Unknown Facility
São Paulo, São Paulo, 01246-000, Brazil
Unknown Facility
São Paulo, São Paulo, 05652-000, Brazil
Unknown Facility
Gabrovo, 5300, Bulgaria
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Plovdiv, 4004, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Sofia, 1756, Bulgaria
Unknown Facility
Vratsa, 3000, Bulgaria
Unknown Facility
Zagreb, 10000, Croatia
Unknown Facility
Bochum, 44791, Germany
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Esslingen am Neckar, 73730, Germany
Unknown Facility
Greifswald, 17489, Germany
Unknown Facility
Hamburg, 20148, Germany
Unknown Facility
Saarbrücken, 66113, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Hong Kong, 852, Hong Kong
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Bangalore, 560029, India
Unknown Facility
Chennai, 600035, India
Unknown Facility
Jaipur, 302004, India
Unknown Facility
Kochi, 682304, India
Unknown Facility
Kolkata, 700053, India
Unknown Facility
Ludhiana, 141 001, India
Unknown Facility
Mumbai, 400012, India
Unknown Facility
New Delhi, 110076, India
Unknown Facility
Pune, 411 001, India
Unknown Facility
Vellore, 632004, India
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Riga, LV-1002, Latvia
Unknown Facility
Kaunas, 50009, Lithuania
Unknown Facility
Vilnius, 08660, Lithuania
Unknown Facility
Vilnius, 08661, Lithuania
Unknown Facility
George Town, 11200, Malaysia
Unknown Facility
Kuala Lumpur, 59100, Malaysia
Unknown Facility
Monterrey, 64020, Mexico
Unknown Facility
Arequipa, 04001, Peru
Unknown Facility
Chiclayo, CIX, Peru
Unknown Facility
San Isidro, L27 Lima, Peru
Unknown Facility
Bucharest, Romania
Unknown Facility
Cluj-Napoca, 400015, Romania
Unknown Facility
Craiova (Dolj County), 200535, Romania
Unknown Facility
Irkutsk, 664035, Russia
Unknown Facility
Kazan', 420111, Russia
Unknown Facility
Krasnodar, 350040, Russia
Unknown Facility
Moscow, 115478, Russia
Unknown Facility
Saint Petersburg, 195067, Russia
Unknown Facility
Saint Petersburg, 198255, Russia
Unknown Facility
Singapore, 169610, Singapore
Unknown Facility
Ljubljana, 1000, Slovenia
Unknown Facility
Kiev, 36022, Ukraine
Unknown Facility
London, EC1A 7BE, United Kingdom
Unknown Facility
London, N18 1QX, United Kingdom
Unknown Facility
London, SE1 9RT, United Kingdom
Unknown Facility
London, SW3 6JJ, United Kingdom
Unknown Facility
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Propper D, Davidenko I, Bridgewater J, Kupcinskas L, Fittipaldo A, Hillenbach C, Klughammer B, Ducreux M. Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma. Ann Oncol. 2014 Jul;25(7):1384-1390. doi: 10.1093/annonc/mdu176. Epub 2014 May 14.
PMID: 24827134DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 8, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Study Completion
March 1, 2015
Last Updated
June 17, 2016
Results First Posted
April 26, 2016
Record last verified: 2016-05