Phase 2
N=8
AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
Pancreatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00219557 ↗Enrolled (actual)
8
Serious AEs
44.9%
Results posted
Aug 2012
Primary outcome: Primary: Overall Survival (OS) — 210; 171 Days — p=0.1026
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); AG-013736 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
210; 171 | 0.1026 |
| SECONDARY Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) |
— | — |
| SECONDARY Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) |
— | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736) |
45.08 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736) |
282.34 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736) |
1.52 | — |
| SECONDARY Plasma Decay Half-life (t1/2) of Axitinib (AG-013736) |
2.97 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Gemcitabine |
27280.0 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine |
13656.00 | — |
| SECONDARY Plasma Decay Half-life (t1/2) of Gemcitabine |
0.310 | — |
| SECONDARY Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2 |
— | — |
| SECONDARY Percentage of Participants With Overall Response (OR) |
7.2; 2.9 | 0.661 |
| SECONDARY Duration of Response (DR) |
379; 155 | — |
| SECONDARY Progression-free Survival (PFS) |
116; 113 | 0.4466 |
| SECONDARY One Year Survival Probability |
36.81; 23.53 | — |
| SECONDARY Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study |
55.60; 54.32; 76.90; 82.22; 62.56; 60.26 | — |
| SECONDARY Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study |
37.52; 38.89; 40.40; 33.95; 22.32; 25.31 | — |
Summary
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
Eligibility Criteria
Inclusion Criteria
- patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
- no prior therapy for metastatic disease
Exclusion Criteria
- patients with locally advanced disease who are candidates for radiation therapy.
- uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
Data sourced from ClinicalTrials.gov (NCT00219557). 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.