Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387387
First received: October 11, 2006
Last updated: May 31, 2012
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Colorectal Colorectal Cancer |
Drug: pazopanib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 orCapeOx in Subjects With Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 [ Time Frame: on Day 1, 14 and 21 ]
Secondary Outcome Measures:
- 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 [ Time Frame: collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1. ]
| Enrollment: | 70 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: pazopanib
Other Name: pazopanib
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387387
Locations
| India | |
| GSK Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500482 | |
| GSK Investigational Site | |
| Parel, India, 400012 | |
| United Kingdom | |
| GSK Investigational Site | |
| Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ | |
| GSK Investigational Site | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| GSK Investigational Site | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00387387 History of Changes |
| Other Study ID Numbers: | VEG105424 |
| Study First Received: | October 11, 2006 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
pharmacokinetics colorectal cancer pazopanib capecitabine CapeOx |
5-fluorouracil oxaliplatin combination therapy FOLFOX 6 |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil |
Capecitabine Oxaliplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013