Pancreatic CancerPhase 2NCT00674973
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing Erlotinib in people with Pancreatic Cancer, run by Hoffmann-La Roche at 71 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 71 sitesin 19 countries
- Study dates
- Jun 2008to Mar 2015
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
71 sites in 19 countries.
71 sites in 19 countries
Brazil10 sites
Study site
Belo Horizonte, Minas Gerais, 30110-0090
Study site
Curitiba, Paraná, 81520-060
Study site
Ijuí, Rio Grande do Sul, 98700-000
Study site
Jaú, São Paulo, 17210-080
Study site
Porto Alegre, Rio Grande do Sul, 90020-090
Study site
Porto Alegre, Rio Grande do Sul, 90430-090
Study site
Porto Alegre, Rio Grande do Sul, 91350-200
Study site
Salvador, Bahia, Estado de Bahia, 40170-380
Study site
São Paulo, São Paulo, 01246-000
Study site
São Paulo, São Paulo, 05652-000
India10 sites
Study site
Bangalore, 560029
Study site
Chennai, 600035
Study site
Jaipur, 302004
Study site
Kochi, 682304
Study site
Kolkata, 700053
Study site
Ludhiana, 141 001
Study site
Mumbai, 400012
Study site
New Delhi, 110076
Study site
Pune, 411 001
Study site
Vellore, 632004
Germany8 sites
Study site
Bochum, 44791
Study site
Cologne, 50937
Study site
Dresden, 01307
Study site
Esslingen am Neckar, 73730
Study site
Greifswald, 17489
Study site
Hamburg, 20148
Study site
Saarbrücken, 66113
Study site
Ulm, 89081
Bulgaria7 sites
Study site
Gabrovo, 5300
Study site
Pleven, 5800
Study site
Plovdiv, 4004
Study site
Sofia, 1233
Study site
Sofia, 1431
Study site
Sofia, 1756
Study site
Vratsa, 3000
Russia6 sites
Study site
Irkutsk, 664035
Study site
Kazan', 420111
Study site
Krasnodar, 350040
Study site
Moscow, 115478
Study site
Saint Petersburg, 195067
Study site
Saint Petersburg, 198255
United Kingdom5 sites
Study site
London, EC1A 7BE
Study site
London, N18 1QX
Study site
London, SE1 9RT
Study site
London, SW3 6JJ
Study site
Sutton, SM2 5PT
Australia4 sites
Study site
Box Hill, Victoria, 3128
Study site
Kogarah, New South Wales, 2217
Study site
St Leonards, New South Wales, 2065
Study site
Sydney, New South Wales, 2076
Lithuania3 sites
Study site
Kaunas, 50009
Study site
Vilnius, 08660
Study site
Vilnius, 08661
Peru3 sites
Study site
Arequipa, 04001
Study site
Chiclayo, CIX
Study site
San Isidro, L27 Lima
Romania3 sites
Study site
Bucharest
Study site
Cluj-Napoca, 400015
Study site
Craiova (Dolj County), 200535
Italy2 sites
Study site
Bologna, Emilia-Romagna, 40138
Study site
Udine, Friuli Venezia Giulia, 33100
About this study
Official title: A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Erlotinib, Placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Participants received erlotinib 150 mg tablet orally once daily.
PlaceboDrug
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Participants 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. Receives: Drug: Erlotinib |
| Placebo | Placebo comparator | Participants 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Measured: From the time of randomization until progression of disease or death (up to 30 months)
Percentage of Participants With Disease Control Rate (DCR)
Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Measured: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Measured: From the time of randomization until or death (up to 30 months)
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Measured: Up to 28 days after discontinuation of study drug (up to 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionMar 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674973
- Sponsor's protocol ID
- BO21129
- Other IDs
- 2007-003738-40
- Status last verified
- May 2016
- First submitted
- 30 Apr 2008
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24827134
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00674973
- Acronym / sponsor ID
- BO21129
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 26 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibParticipants 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 comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| ErlotinibAlso: TarcevaParticipants received erlotinib 150 mg tablet orally once daily. | Drug | Erlotinib |
| PlaceboParticipants received placebo matching to erlotinib 150 mg tablet orally once daily. | Drug | Placebo |
Primary outcome
Progression-Free Survival
Time frame: From the time of randomization until progression of disease or death (up to 30 months)
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.
4 secondary outcomes
Percentage of Participants With Best Overall Response Rate
Time frame: From the time of randomization until progression of disease or death (up to 30 months)
Percentage of Participants With Disease Control Rate (DCR)
Time frame: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Overall Survival
Time frame: From the time of randomization until or death (up to 30 months)
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 days after discontinuation of study drug (up to 30 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24827134Propper 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.
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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.
Clinical Trials study director
Hoffmann-La Roche
71 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib in people with Pancreatic Cancer, run by Hoffmann-La Roche at 71 sites in 19 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 5 inclusion and 3 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 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Brazil, India, Germany, Bulgaria, Russia and 14 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. Some participants in this study may receive a placebo. 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 26 Apr 2016). 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?
Progression-Free Survival (time frame: From the time of randomization until progression of disease or death (up to 30 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674973, which also lists 1 linked publication.
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 Jun 2016.