Phase 1
Completed N=22
Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT00842244 ↗Enrolled (actual)
22
Serious AEs
54.6%
Results posted
Mar 2012
Primary outcomePrimary: Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) — 3 participants
Summary
The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) |
3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
16.11; 24.33; 5255.62; 2274.80; 220.49; 90.97 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
3.98; 4.00; 2.45; 3.12; 2.50; 2.62 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin |
7109.59; 4194.97; 332.37; 176.81; 9996.55; 6683.33 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib |
206.20; 265.89 | — |
| SECONDARY Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
147.04; 156.00; 7140.62; 4213.72; 337.85; 261.95 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
5.76; 3.50; 0.71; 0.89; 1.11; 1.05 | — |
| SECONDARY Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites |
48.55; 37.69; 217.60; 368.47 | — |
| SECONDARY Clearance (CL) for Cisplatin |
30.94; 32.50 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites |
344.87; 171.83; 190.94; 425.00 | — |
| SECONDARY Volume of Distribution (Vz) for Cisplatin |
55.35; 70.32 | — |
| SECONDARY Drug Metabolizing Enzyme Genotyping |
— | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
36.36 | — |
| SECONDARY Duration of Response (DR) |
9.07 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.75 | — |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of stomach cancer
- advanced stomach cancer of stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and sign an informed consent document
Exclusion Criteria
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Data sourced from ClinicalTrials.gov (NCT00842244). 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.