Clinical trial · Interventional
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 or CapeOx in Subjects With Colorectal Cancer
NCT00387387CI-TRIAL-00030407completedPhase 1ClinicalTrials.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)
This study will test the safety of treating colorectal cancer with a combination of drugs. The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK investigational drug pazopanib.
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 |
|---|---|---|---|
| Neoplasms, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CapeOx | Drug | CAPOX Regimen | ALIAS |
| FOLFOX 6 | Drug | FOLFOX Regimen | ALIAS |
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOX 6 + Pazopanib
- description
- Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
- interventionNames
- Drug: Pazopanib
- Drug: FOLFOX 6
- type
- EXPERIMENTAL
- label
- CapeOx + Pazopanib
- description
- Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m\^2 twice daily.
- interventionNames
- Drug: Pazopanib
- Drug: CapeOx
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of locally advanced or metastatic colorectal cancer. * No prior chemotherapy for metastatic disease. * Presence of radiologically and/or clinically documented disease. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate bone marrow, hepatic, renal function, Urine Creatinine Ratio (UPC) of \< * A female subject must not be pregnant or breast feeding. * Able to swallow and retain oral medications. Exclusion Criteria: * Has had any major surgery, chemotherapy, hormone therapy, investigational agent, or radiotherapy within the last 28 days * Prior treatment with pazopanib, or oxaliplatin. * Known contraindications to the use of oxaliplatin, capecitabine, 5-fluorouracil, or folinic acid. * Participation in any investigational study within 28 days prior to study treatment. * Women who are pregnant or lactating. * Poorly controlled hypertension. * A history of cardiovascular disease, arrhythmias, or significant ECG abnormalities. * Any history of stroke. * Current use of therapeutic warfarin. * Known brain metastases. * History of disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel. * Active infections or other serious illness. * History of allergy to platinum compounds or heparin. * Poor venous access.
References
Publications (1)
- DERIVEDBrady J, Corrie P, Chau I, Digumarti R, Adams LM, Botbyl J, Laubscher KH, Midgley RS, Mallath M. An open-label study of the safety and tolerability of pazopanib in combination with FOLFOX6 or CapeOx in patients with colorectal cancer. Invest New Drugs. 2013 Oct;31(5):1228-35. doi: 10.1007/s10637-013-9938-7. Epub 2013 Feb 28. PMID 23456563