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

November 13, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, Andhra Pradesh, India, 500482
        • GSK Investigational Site
      • Parel, India, 400012
        • GSK Investigational Site
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • GSK Investigational Site
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • GSK Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FOLFOX 6 + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
Drug: Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
Drug: FOLFOX 6
FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter^2[mg/m^2]), and folinic acid (400 mg/m^2), IV 5-fluorouracil bolus (400 mg/m^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m^2) infusion over 48 hours on Day 1 of every 14-day cycle.
Experimental: CapeOx + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m^2 twice daily.
Drug: Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
Drug: CapeOx
CapeOx treatment consists of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m^2 twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
on Day 1, 14 and 21

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2006

Primary Completion (Actual)

August 14, 2009

Study Completion (Actual)

August 14, 2009

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEG105424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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