Status:
COMPLETED
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Colorectal
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00387387
Start Date
October 20 2006
End Date
August 14 2009
Last Update
November 17 2017
Active Locations (5)
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1
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
2
GSK Investigational Site
Pārel, India, 400012
3
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
4
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ