Phase 3
Completed N=607
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT01214720 ↗Enrolled (actual)
607
Serious AEs
44.3%
Results posted
Aug 2014
Primary outcomePrimary: Duration of Overall Survival - Percentage of Participants With an Event — 72.2; 77.4 percentage of participants
Summary
This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Overall Survival - Percentage of Participants With an Event |
72.2; 77.4 | — |
| PRIMARY Duration of Overall Survival - Time to Event |
7.1; 6.0 | 0.2087 |
| SECONDARY Clinical Benefit Response (CBR) |
— | — |
| SECONDARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
84.0; 92.4 | — |
| SECONDARY Progression-Free Survival (PFS) - Time to Event |
4.6; 3.6 | 0.0002 sig |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment |
62.1; 58.5 | 0.3621 |
| SECONDARY Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib |
0.52; 27.09; 35.23; 41.19; 44.60 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
Exclusion Criteria
- previous systemic treatment for metastatic pancreatic cancer;
- pregnant or lactating females;
- fertile men, or women of childbearing potential, not using adequate contraception;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
Data sourced from ClinicalTrials.gov (NCT01214720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.