Trial · NCT01214720
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
NCT01214720, Phase 3, Completed, Hoffmann-La Roche; results first posted 2014-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer. Trials, record NCT01214720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214720
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
- NCT number
- NCT01214720
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 607 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Cancer
- Interventions
- bevacizumab [Avastin]
- First posted
- 2010-10-05
- Last updated
- 2014-08-13
- Results first posted
- 2014-08-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Overall Survival - Percentage of Participants With an Event | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. |
| Primary | Duration of Overall Survival - Time to Event | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method. |
| Secondary | Clinical Benefit Response (CBR) | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | |
| Secondary | Progression-Free Survival (PFS) - Percentage of Participants With an Event | Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression | PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. |
| Secondary | Progression-Free Survival (PFS) - Time to Event | Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression | PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment | Baseline and Week 8 | Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. |
| Secondary | Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib | Weeks 1, 3, 5, 7, and 9 | Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Overall Survival - Percentage of Participants With an Event | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Response (CBR) | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study. | ||
| SECONDARY | Progression-Free Survival (PFS) - Percentage of Participants With an Event | Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) - Time to Event | Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression | ITT Population | months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment | Baseline and Week 8 | ITT Population. | percentage of participants | NUMBER |
| PRIMARY | Duration of Overall Survival - Time to Event | Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized | ITT Population. | months | MEDIAN |
| SECONDARY | Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib | Weeks 1, 3, 5, 7, and 9 | ITT Population. Number (n) = number of participants assessed at a specific visit. | micrograms/milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Overall Survival - Percentage of Participants With an Event | Bevacizumab + Gemcitabine + Erlotinib | 72.2 | percentage of participants | ||
| Duration of Overall Survival - Percentage of Participants With an Event | Placebo + Gemcitabine + Erlotinib | 77.4 | percentage of participants | ||
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Bevacizumab + Gemcitabine + Erlotinib | 84.0 | percentage of participants | ||
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Placebo + Gemcitabine + Erlotinib | 92.4 | percentage of participants | ||
| Progression-Free Survival (PFS) - Time to Event | Bevacizumab + Gemcitabine + Erlotinib | 4.6 | 95% Confidence Interval 3.9 to 5.4 | months | |
| Progression-Free Survival (PFS) - Time to Event | Placebo + Gemcitabine + Erlotinib | 3.6 | 95% Confidence Interval 3.4 to 3.7 | months | |
| Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment | Bevacizumab + Gemcitabine + Erlotinib | 62.1 | 95% Confidence Interval 56.4 to 67.6 | percentage of participants | |
| Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment | Placebo + Gemcitabine + Erlotinib | 58.5 | 95% Confidence Interval 52.7 to 64.1 | percentage of participants | |
| Duration of Overall Survival - Time to Event | Bevacizumab + Gemcitabine + Erlotinib | 7.1 | 95% Confidence Interval 6.4 to 7.8 | months | |
| Duration of Overall Survival - Time to Event | Placebo + Gemcitabine + Erlotinib | 6.0 | 95% Confidence Interval 5.5 to 6.7 | months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab + Gemcitabine + Erlotinib | 306 | |
| Overall Study | STARTED | Placebo + Gemcitabine + Erlotinib | 301 | |
| Overall Study | COMPLETED | Bevacizumab + Gemcitabine + Erlotinib | 221 | |
| Overall Study | COMPLETED | Placebo + Gemcitabine + Erlotinib | 233 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Gemcitabine + Erlotinib | 85 | |
| Overall Study | NOT COMPLETED | Placebo + Gemcitabine + Erlotinib | 68 |
Source ClinicalTrials.gov
Adverse events440
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 | Bevacizumab + Gemcitabine + Erlotinib | 145 | 297 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Gemcitabine + Erlotinib | 144 | 286 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab + Gemcitabine + Erlotinib | 135 | 297 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Gemcitabine + Erlotinib | 146 | 286 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + Gemcitabine + Erlotinib | 108 | 297 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + Gemcitabine + Erlotinib | 118 | 286 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Gemcitabine + Erlotinib | 79 | 297 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Gemcitabine + Erlotinib | 65 | 286 | |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab + Gemcitabine + Erlotinib | 46 | 297 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Gemcitabine + Erlotinib | 39 | 286 |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Gemcitabine + Erlotinib | ||
| Total, all-cause mortality | Placebo + Gemcitabine + Erlotinib | ||
| Total, other adverse events | Bevacizumab + Gemcitabine + Erlotinib | 290 | 297 |
| Total, other adverse events | Placebo + Gemcitabine + Erlotinib | 276 | 286 |
| Total, serious adverse events | Bevacizumab + Gemcitabine + Erlotinib | 139 | 297 |
| Total, serious adverse events | Placebo + Gemcitabine + Erlotinib | 119 | 286 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bevacizumab + Gemcitabine + Erlotinib vs Placebo + Gemcitabine + Erlotinib: serious adverse events |
Source 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/NCT01214720
GET https://conductscience.org/api/trials/v1/NCT01214720/events?page=2