Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)

Neoplasms, Colorectal Clinical Trial

Official title:

An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 or CapeOx in Subjects With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387387
• Other study ID #: VEG105424
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2006
• Last updated: November 13, 2017
• Start date: October 20, 2006
• Est. completion date: August 14, 2009

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 14, 2009
• Est. primary completion date: August 14, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms, Colorectal

Intervention

Drug:
• Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
• FOLFOX 6
FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter^2[mg/m^2]), and folinic acid (400 mg/m^2), IV 5-fluorouracil bolus (400 mg/m^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m^2) infusion over 48 hours on Day 1 of every 14-day cycle.
• CapeOx
CapeOx treatment consists 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 will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m^2 twice daily.

Locations

Country	Name	City	State
India	GSK Investigational Site	Hyderabad, Andhra Pradesh
India	GSK Investigational Site	Parel
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire
United Kingdom	GSK Investigational Site	Oxford	Oxfordshire
United Kingdom	GSK Investigational Site	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma AUC(0-24) of pazopanib on Day 1, 14 and 21 Plasma AUC(0-46) of 5-FU and AUC(0-8) of platinum on Day 1 Plasma AUC(0-24) of capecitabine, 5-FU, and platinum on Day 1		on Day 1, 14 and 21
Secondary	Pharmacokinetic endpoints (AUC, C24, Cmax, tmax, and half-life)collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1. Assessment of disease by imaging		collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.

External Links

•   Results for study VEG105424 can be found on the GSK Clinical Study Register.