Phase 3
Completed N=630
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Source: ClinicalTrials.gov NCT00471146 ↗Enrolled (actual)
630
Serious AEs
34.3%
Results posted
Jul 2012
Primary outcomePrimary: Overall Survival (OS) — 36.9; 35.8 Weeks — p=0.5436
Summary
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
36.9; 35.8 | 0.5436 |
| SECONDARY Progression Free Survival (PFS) |
19.1; 18.9 | 0.5203 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
4.9; 1.6 | 0.038 sig |
| SECONDARY Duration of Response (DR) |
33.1; NA | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score |
77.445; 78.546; -2.713; -3.261; -5.897; -1.565 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score |
41.6; 40.0; -10.9; -10.1; -16.3; -11.2 | — |
| SECONDARY Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score |
3.8; 3.7; -0.7; -0.9; -1.5; -0.9 | — |
| SECONDARY Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile |
0.665; 0.690; 0.050; 0.020; 0.053; 0.028 | — |
| SECONDARY Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score |
60.6; 62.6; 1.0; -0.4; 2.6; 1.1 | — |
| SECONDARY Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
- Adequate renal, hepatic and bone marrow function.
- Performance status 0 or 1.
Exclusion Criteria
- Prior treatment with any systemic chemotherapy for metastatic disease.
- Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
- Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
- Inability to take oral medication.
Data sourced from ClinicalTrials.gov (NCT00471146). 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.