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


Phase 1
21 Years
N/A
Not Enrolling
Both
Neoplasms, Colorectal, Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

on Day 1, 14 and 21

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

VEG105424

NCT ID:

NCT00387387

Start Date:

October 2006

Completion Date:

June 2009

Related Keywords:

  • Neoplasms, Colorectal
  • Colorectal Cancer
  • pharmacokinetics
  • colorectal cancer
  • pazopanib
  • capecitabine
  • CapeOx
  • 5-fluorouracil
  • oxaliplatin
  • combination therapy
  • FOLFOX 6
  • Neoplasms
  • Colorectal Neoplasms

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