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
1 other identifier
interventional
50
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2006
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedStudy Start
First participant enrolled
October 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2009
CompletedNovember 17, 2017
November 1, 2017
2.8 years
October 11, 2006
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
FOLFOX 6 + Pazopanib
EXPERIMENTALSubjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
CapeOx + Pazopanib
EXPERIMENTALSubjects 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.
Interventions
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (5)
GSK Investigational Site
Hyderabad, Andhra Pradesh, 500482, India
GSK Investigational Site
Pārel, 400012, India
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
GSK Investigational Site
Sutton, Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Brady 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: 23456563DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
October 20, 2006
Primary Completion
August 14, 2009
Study Completion
August 14, 2009
Last Updated
November 17, 2017
Record last verified: 2017-11