Neoplasms, ColorectalPhase 1NCT00387387
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
A Phase 1 study testing Pazopanib, FOLFOX 6 and CapeOx in people with Neoplasms, Colorectal, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neoplasms, Colorectal
- What is being tested?
- Pazopanib, FOLFOX 6 and CapeOx
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Oct 2006to 14 Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom3 sites
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2QQ
GSK Investigational Site
Oxford, Oxfordshire, OX3 7LJ
GSK Investigational Site
Sutton, Surrey, SM2 5PT
India2 sites
GSK Investigational Site
Hyderabad, Andhra Pradesh, 500482
GSK Investigational Site
Parel, 400012
About this study
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
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.
- Conditions
- Neoplasms, Colorectal
- Being tested
- Pazopanib, FOLFOX 6, CapeOx
- Keywords
- pharmacokinetics, colorectal cancer, pazopanib, capecitabine, CapeOx, 5-fluorouracil, oxaliplatin, combination therapy, FOLFOX 6
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
FOLFOX 6Drug
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.
CapeOxDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX 6 + Pazopanib | Experimental | Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6. Receives: Drug: Pazopanib; Drug: FOLFOX 6 |
| CapeOx + Pazopanib | Experimental | 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. Receives: Drug: Pazopanib; Drug: CapeOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study start20 Oct 2006
- Primary completion14 Aug 2009
- Study completion14 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, ColorectalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387387
- Sponsor's protocol ID
- VEG105424
- Status last verified
- Nov 2017
- First submitted
- 11 Oct 2006
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00387387
- Acronym / sponsor ID
- VEG105424
- Conditions
- Neoplasms, Colorectal
- Keywords
- pharmacokinetics, colorectal cancer, pazopanib, capecitabine, CapeOx, 5-fluorouracil, oxaliplatin, combination therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2006 (actual)
- Primary completion
- 14 Aug 2009 (actual)
- Study completion
- 14 Aug 2009 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX 6 + Pazopanib | Experimental | Drug: Pazopanib, Drug: FOLFOX 6Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6. |
| CapeOx + Pazopanib | Experimental | Drug: Pazopanib, Drug: CapeOxSubjects 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 <
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibPazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases | Drug | CapeOx + Pazopanib, FOLFOX 6 + Pazopanib |
| FOLFOX 6FOLFOX 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. | Drug | FOLFOX 6 + Pazopanib |
| CapeOxCapeOx 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. | Drug | CapeOx + Pazopanib |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 23456563Brady 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.
- Results for study VEG105424 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pazopanib, FOLFOX 6 and CapeOx in people with Neoplasms, Colorectal, run by GlaxoSmithKline at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.