Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

A Phase 1 study testing sunitinib + mFOLFOX6 in people with Colorectal Neoplasms, run by Pfizer at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Colorectal Neoplasms
What is being tested?: sunitinib + mFOLFOX6
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 3 sitesJapan
Study dates: Jan 2008to Mar 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
Prior surgery or investigational agent within 4 weeks prior to study entry.
Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Pfizer Investigational Site
Chuo-ku, Tokyo
Pfizer Investigational Site
Kashiwa, Chiba
Pfizer Investigational Site
Suntougun, Shizuoka

Other trials in Japan

About this study

Official title: Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer

To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.

Conditions: Colorectal Neoplasms
Being tested: sunitinib + mFOLFOX6
Keywords: Phase 1, CRC, SU011248, Sunitinib, FOLFOX, Colorectal cancer, metastatic carcinoma of the colon or rectum
Medical subject headings: Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sunitinib + mFOLFOX6Drug
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
sunitinib + mFOLFOX6Drug
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

Study groups in NCT00631410
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: sunitinib + mFOLFOX6
B	Experimental	Not described Receives: Drug: sunitinib + mFOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
Measured: Up to 733 days (the last subject study discontinuation)

Secondary outcomes (8)

Plasma Concentration of Sunitinib
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Measured: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of Sunitinib Active Metabolite (SU012662)
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Measured: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Measured: Cycle 1 Day 14 and Cycle 2 Day 1
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.
Measured: Up to the last subject completed Cycle 24 or individual study discontinuation
Duration of Response (DR)
Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.
Measured: Up to 733 days (the last subject study discontinuation)
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.
Measured: Up to 733 days (the last subject study discontinuation)
Sunitinib Relative Dose Intensity in the Treatment Arm A
Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)*3+1 to n*3.
Measured: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
Sunitinib Relative Dose Intensity in the Treatment Arm B
Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)*2+1 to n*2.
Measured: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2010

First posted7 Mar 2008 (estimated)
Study startJan 2008
Primary completionJul 2009
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631410
Sponsor's protocol ID: A6181148
Status last verified: Mar 2011
First submitted: 2 Jan 2008
Last updated: 16 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
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All Colorectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00631410
Acronym / sponsor ID: A6181148
Conditions: Colorectal Neoplasms
Keywords: Phase 1, CRC, SU011248, Sunitinib, FOLFOX, Colorectal cancer, metastatic carcinoma of the colon or rectum
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jul 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 17 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: sunitinib + mFOLFOX6
B	Experimental	Drug: sunitinib + mFOLFOX6

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key exclusion criteria (3 listed)

Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
Prior surgery or investigational agent within 4 weeks prior to study entry.
Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.

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
sunitinib + mFOLFOX637.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)	Drug	A
sunitinib + mFOLFOX650 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)	Drug	B

Primary outcome

Number of Participants With Adverse Events
Time frame: Up to 733 days (the last subject study discontinuation)
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.

8 secondary outcomes

Plasma Concentration of Sunitinib
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of Sunitinib Active Metabolite (SU012662)
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to the last subject completed Cycle 24 or individual study discontinuation
Duration of Response (DR)
Time frame: Up to 733 days (the last subject study discontinuation)
Progression-Free Survival (PFS)
Time frame: Up to 733 days (the last subject study discontinuation)
Sunitinib Relative Dose Intensity in the Treatment Arm A
Time frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
Sunitinib Relative Dose Intensity in the Treatment Arm B
Time frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)

Results and safety

Results posted to the registry on 17 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm A 37.5 mg/Day (4/2)	6	0
Treatment Arm B 50 mg/Day (2/2)	6	0

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 733 days (the last subject study discontinuation). Number. Unit: participants

Measure	Treatment Arm A 37.5 mg/Day (4/2) n = 6	Treatment Arm B 50 mg/Day (2/2) n = 6
Any adverse events	6	6
Any serious adverse evets	2	4
Any Grade-3 or -4 adverse evets	6	6
Any Grade-5 adverse events (= death)	0	0
Discontinuation due to adverse events	1	3
Sunitinib interruption due to adverse events	6	6
mFOLFOX6 interruption due to adverse events	6	6
Sunitinib dose reduction due to adverse events	1	1

Population analysed: All subjects who received at least 1 dose of the study drug.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 733 days (the last subject study discontinuation). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm A 37.5 mg/Day (4/2)	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Treatment Arm B 50 mg/Day (2/2)	4 of 6 (66.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Colorectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sunitinib + mFOLFOX6 in people with Colorectal Neoplasms, run by Pfizer at 3 sites in Japan.

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 3 inclusion and 3 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 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 17 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: Up to 733 days (the last subject study discontinuation)). 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 NCT00631410.

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 16 Mar 2011.