Clinical trial · Interventional
A Study of Pazopanib With CAPEOX in AGC Patients
A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer
NCT01130805CI-TRIAL-00021765completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In order to improve survival of metastatic gastric cancer patients, we plan to to conduct a phase II trial of CapeOx with 800 mg once-daily pazopanib as a first-line chemotherapy in metastatic gastric cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib in combination with capecitabine and oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib in combination with capecitabine and oxaliplatin
- description
- Capecitabine 850 mg/m2 bid on day 1-14, Oxaliplatin 130 mg/m2 IV on day 1 and Pazopanib 800 mg once in a day on day 1-21, every 3 weeks
- interventionNames
- Drug: Pazopanib in combination with capecitabine and oxaliplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 6 months after last patient
Secondary outcomes (4)
- measure
- Progression free survival (PFS)
- timeFrame
- one year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who provide written informed consent * Age over 18 years * Histologically proven unresectable gastric cancer * ECOG performance status of 0-2 * At least one uni-dimensionally measurable lesion by RECIST criteria ver 1.1 * Adequate organ system function absolute neutrophil count \> 1,500/µL, platelets \> 100,000/µL, hemoglobin \> 9g/dl Total bilirubin \< 1.5 times upper limit of normal (ULN), AST and ALT \< 2.5 times ULN, PT (INR), PTT \< 1.2 times UNL Serum creatinine less than 1.5 mg/dL or Calculated Ccr at least 50 mL/min, Urine Protein to Creatinine Ratio (UPC) less than 1 * female with Non-childbearing potential Exclusion Criteria: * Prior malignancy * History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug * Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including * Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product * Presence of uncontrolled infection * Corrected QT interval (QTc) above 480 msecs using Bazett's formula * History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class II or higher congestive heart failure * Poorly controlled hypertension while on antihypertensive agents * History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months * Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer * Evidence of active bleeding or bleeding diathesis * Hemoptysis within 6 weeks of first dose of study drug * Any serious and/or unstable preexisting medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures * Unable or unwilling to discontinue use of prohibited medications listed in the protocol * Treatment with any of the following anti-cancer therapies;Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib; biologic therapy, immunotherapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib; No prior chemotherapy except adjuvant chemotherapy (Patients who received adjuvant chemotherapy at least 6 months prior to study entry will be allowed regardless of chemotherapeutic regimen * Pre-existing grade 2 (or higher) motor or sensory neuropathy by CTCAE v4.0 * Known allergy to study drugs
References
Publications (2)
- RESULTKim ST, Lee J, Lee SJ, Park SH, Jung SH, Park YS, Lim HY, Kang WK, Park JO. Prospective phase II trial of pazopanib plus CapeOX (capecitabine and oxaliplatin) in previously untreated patients with advanced gastric cancer. Oncotarget. 2016 Apr 26;7(17):24088-96. doi: 10.18632/oncotarget.8175. PMID 27003363
- DERIVEDKim ST, Ahn S, Lee J, Lee SJ, Park SH, Park YS, Lim HY, Kang WK, Kim KM, Park JO. Value of FGFR2 expression for advanced gastric cancer patients receiving pazopanib plus CapeOX (capecitabine and oxaliplatin). J Cancer Res Clin Oncol. 2016 Jun;142(6):1231-7. doi: 10.1007/s00432-016-2143-2. Epub 2016 Mar 16. PMID 26983912