Last updated: 11/07/2018 19:53:33
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: on Day 1, 14 and 21
Secondary outcomes:
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
Timeframe: collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.
Interventions:
Drug: Pazopanib
Drug: FOLFOX 6
Drug: CapeOx
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Brady J, Corrie P, Chau I, et al. An Open-Label Pharmacokinetic 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.
Medical condition
Neoplasms, Colorectal
Product
pazopanib
Collaborators
Not applicable
Study date(s)
October 2006 to August 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- Diagnosis of locally advanced or metastatic colorectal cancer.
- No prior chemotherapy for metastatic disease.
- Has had any major surgery, chemotherapy, hormone therapy, investigational agent,
- or radiotherapy within the last 28 days
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study VEG105424 can be found on the GSK Clinical Study Register.
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