Trial · NCT00674973
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
NCT00674973, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer. Trials, record NCT00674973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00674973
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
- NCT number
- NCT00674973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 207 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Cancer
- Interventions
- Erlotinib, Placebo
- First posted
- 2008-05-08
- Last updated
- 2016-06-17
- Other registries' IDs
- eudract:2007-003738-40
- Results first posted
- 2016-04-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival | 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. |
| Secondary | Percentage of Participants With Best Overall Response Rate | From the time of randomization until progression of disease or death (up to 30 months) | 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. |
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months) | 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. |
| Secondary | Overall Survival | From the time of randomization until or death (up to 30 months) | Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 28 days after discontinuation of study drug (up to 30 months) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival | From the time of randomization until progression of disease or death (up to 30 months) | The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response Rate | From the time of randomization until progression of disease or death (up to 30 months) | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control Rate (DCR) | Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months) | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From the time of randomization until or death (up to 30 months) | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 28 days after discontinuation of study drug (up to 30 months) | Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival | Placebo | 5.9 | 95% Confidence Interval 5.4 to 6.1 | weeks | |
| Progression-Free Survival | Erlotinib | 6.1 | 95% Confidence Interval 5.9 to 6.4 | weeks | |
| Percentage of Participants With Best Overall Response Rate | Placebo | CR | 0 | 95% Confidence Interval 0.0 to 3.5 | percentage of participants |
| Percentage of Participants With Best Overall Response Rate | Erlotinib | CR | 0 | 95% Confidence Interval 0.0 to 3.5 | percentage of participants |
| Percentage of Participants With Best Overall Response Rate | Placebo | PR | 4 | 95% Confidence Interval 1.1 to 9.6 | percentage of participants |
| Percentage of Participants With Best Overall Response Rate | Erlotinib | PR | 1 | 95% Confidence Interval 0.0 to 5.2 | percentage of participants |
| Percentage of Participants With Disease Control Rate (DCR) | Placebo | 19 | 95% Confidence Interval 11.5 to 27.3 | percentage of participants | |
| Percentage of Participants With Disease Control Rate (DCR) | Erlotinib | 29 | 95% Confidence Interval 19.5 to 37.5 | percentage of participants | |
| Overall Survival | Placebo | 3.1 | 95% Confidence Interval 2.1 to 4.3 | months | |
| Overall Survival | Erlotinib | 4.0 | 95% Confidence Interval 2.8 to 4.8 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 103 | |
| Overall Study | STARTED | Erlotinib | 104 | |
| Overall Study | Switch to Open-Label Erlotinib | Placebo | 57 | |
| Overall Study | Switch to Open-Label Erlotinib | Erlotinib | 0 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | COMPLETED | Erlotinib | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 100 | |
| Overall Study | NOT COMPLETED | Erlotinib | 102 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 23 | 103 | |
| other | DIARRHOEA | Gastrointestinal disorders | Erlotinib | 25 | 104 | |
| other | VOMITING | Gastrointestinal disorders | Placebo | 21 | 103 | |
| other | VOMITING | Gastrointestinal disorders | Erlotinib | 13 | 104 | |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 10 | 103 | |
| other | NAUSEA | Gastrointestinal disorders | Erlotinib | 22 | 104 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 15 | 103 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Erlotinib | 16 | 104 | |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo | 17 | 103 | |
| other | CONSTIPATION | Gastrointestinal disorders | Erlotinib | 8 | 104 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Erlotinib | ||
| Total, other adverse events | Placebo | 70 | 103 |
| Total, other adverse events | Erlotinib | 81 | 104 |
| Total, serious adverse events | Placebo | 11 | 103 |
| Total, serious adverse events | Erlotinib | 21 | 104 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24827134 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Erlotinib vs Placebo: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Erlotinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00674973
GET https://conductscience.org/api/trials/v1/NCT00674973/events?page=2