Last updated: 11/07/2018 19:53:33

Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)

GSK study ID
VEG105424
See study documents
Clinicaltrials.gov ID
NCT00387387
EudraCT ID
2006-000241-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Sutton, Surrey, United Kingdom, SM2 5PT
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Oxford, Oxfordshire, United Kingdom, OX3 7LJ
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Hyderabad, Andhra Pradesh, India, 500482
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Parel, India, 400012
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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.
    Click here
    Access to clinical trial data by researchers
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