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CompletedNCT00387387Updated Nov 17, 2017

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

A Phase 1 interventional study of Pazopanib and FOLFOX 6 in Neoplasms, Colorectal, sponsored by GlaxoSmithKline. Completed at 5 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neoplasms, Colorectal

Keywords

  • pharmacokinetics
  • colorectal cancer
  • pazopanib
  • capecitabine
  • CapeOx
  • 5-fluorouracil
  • oxaliplatin
  • combination therapy
  • FOLFOX 6
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 50 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    FOLFOX 6 + Pazopanib

    Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.

    Drug: Pazopanib · Drug: FOLFOX 6

  • 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 · Drug: CapeOx

Interventions

  • DrugPazopanib

    Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases

  • DrugFOLFOX 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.

  • DrugCapeOx

    Drug page: Xelox

    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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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.

07

Study locations

5 sites
  • GSK Investigational Site
    Hyderabad, Andhra Pradesh, 500482, India
  • GSK Investigational Site
    Pārel, 400012, India
  • GSK Investigational Site
    Cambridge, Cambridgeshire CB2 2QQ, United Kingdom
  • GSK Investigational Site
    Oxford, Oxfordshire OX3 7LJ, United Kingdom
  • GSK Investigational Site
    Sutton, Surrey SM2 5PT, United Kingdom
08

References and documents

Publications

  • Brady J, Corrie P, Chau I, Digumarti R, Adams LM, Botbyl J, Laubscher KH, Midgley RS, Mallath M. An open-label 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. doi: 10.1007/s10637-013-9938-7. Epub 2013 Feb 28. PubMed 23456563 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2006 to primary completion in Aug 2009, 33 months.

Of 201 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 67. This study's 33 months is below that.

Counting every sponsor, half of 342 studies reached it within 49 months; a quarter within 32 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2006
First posted
Oct 13, 2006
StartActual
Oct 20, 2006
Primary completionActual
Aug 14, 2009
CompletionActual
Aug 14, 2009
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00387387
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 13, 2006
Start date
Oct 20, 2006
Primary completion
Aug 14, 2009
Completion
Aug 14, 2009
Last update
Nov 17, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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