Breast NeoplasmsPhase 1NCT00291577

Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

A Phase 1 study testing Sunitinib (Sutent) and Taxotere in people with Breast Neoplasms, run by Pfizer at 3 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Sunitinib (Sutent) and Taxotere
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 3 sitesin 3 countries
Study dates: Jul 2006to Feb 2009
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
Candidate for treatment with docetaxel

Who cannot join

Prior chemotherapy in the advanced disease setting
Inflammatory breast cancer
HER2 positive disease

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Belgium1 site

Pfizer Investigational Site
Brussels, 1000

Other trials in Belgium

Italy1 site

Pfizer Investigational Site
Milan, 20133

Other trials in Italy

Sweden1 site

Pfizer Investigational Site
Stockholm, 171 76

Other trials in Sweden

About this study

Official title: Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer

Conditions: Breast Neoplasms
Being tested: Sunitinib (Sutent), Taxotere
Keywords: advanced, sunitinib (Sutent), docetaxel, Phase 1B
Medical subject headings: Breast Neoplasms

What participants receive

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

Sunitinib (Sutent)Drug
Also called Sutent
Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision
TaxotereDrug
Taxotere 75 mg/m2 iv, once every 3 weeks

Study groups in NCT00291577
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Sunitinib (Sutent); Drug: Taxotere

What is being measured

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

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Measured: 1, 2, 4, 6, 8, 12, 24 hours postdose
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Measured: 1, 2, 4, 6, 8, 12, 24 hours postdose
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Measured: 1, 2, 4, 6, 8, 12, 24 hours postdose
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Measured: 1, 2, 4, 6, 8, 12, 24 hours postdose
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Measured: 0 hour postdose
Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Secondary outcomes (4)

Progression-Free Survival (PFS) Based on Investigator Assessment
Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.
Measured: First dose of study treatment until progressive disease
Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment
Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Measured: First dose of study treatment until at least 4 weeks after confirmed response or partial response
Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment
Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.
Measured: First dose of study treatment until at least 24 weeks on study
Duration of Tumor Response Based on Investigator Assessment
Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.
Measured: Start of first confirmed CR or PR to first confirmed progression or death

Timeline

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

Jul 2006Feb 2009

First posted14 Feb 2006 (estimated)
Study startJul 2006
Primary completionOct 2008
Study completionFeb 2009

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 Breast 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: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00291577
Sponsor's protocol ID: A6181100
Status last verified: Nov 2009
First submitted: 13 Feb 2006
Last updated: 23 Dec 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer
ClinicalTrials.gov ID: NCT00291577
Acronym / sponsor ID: A6181100
Conditions: Breast Neoplasms
Keywords: advanced, sunitinib (Sutent), docetaxel, Phase 1B
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Oct 2008 (actual)
Study completion: Feb 2009 (actual)
First posted: 14 Feb 2006 (estimated)
Results: Posted 23 Dec 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Sunitinib (Sutent), Drug: Taxotere

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
Candidate for treatment with docetaxel

Key exclusion criteria (3 listed)

Prior chemotherapy in the advanced disease setting
Inflammatory breast cancer
HER2 positive disease

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 (Sutent)Also: SutentSunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision	Drug	1
TaxotereTaxotere 75 mg/m2 iv, once every 3 weeks	Drug	1

Primary outcome

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Time frame: 0 hour postdose
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.

4 secondary outcomes

Progression-Free Survival (PFS) Based on Investigator Assessment
Time frame: First dose of study treatment until progressive disease
Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment
Time frame: First dose of study treatment until at least 4 weeks after confirmed response or partial response
Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment
Time frame: First dose of study treatment until at least 24 weeks on study
Duration of Tumor Response Based on Investigator Assessment
Time frame: Start of first confirmed CR or PR to first confirmed progression or death

Results and safety

Results posted to the registry on 23 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib in Combination With Docetaxel	22	1

Primary outcome: Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose. Median (Full Range). Unit: hours

Measure	Sunitinib in Combination With Docetaxel n = 11
SU011248 C1D2	6.0 (4.0 to 24.0)
SU011248 C2D3	6.0 (2.0 to 8.0)
SU012662 C1D2	6.0 (2.0 to 24.0)
SU012662 C2D3	6.0 (4.0 to 24.0)
Total drug C1D2	6.0 (2.0 to 24.0)
Total drug C2D3	6.0 (2.0 to 8.0)

Population analysed: Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).

Primary outcome: Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Sunitinib in Combination With Docetaxel n = 11
SU011248 C1D2	29.17 (7.906)
SU011248 C2D3	29.49 (7.910)
SU012662 C1D2	5.07 (2.385)
SU012662 C2D3	5.91 (2.251)
Total drug C1D2	34.05 (9.312)
Total drug C2D3	34.69 (8.941)

Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 98.89 (90% CI 80.34 to 121.73)
Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 81.96 (90% CI 59.76 to 112.41)
Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 97.81 (90% CI 80.44 to 118.94)

Population analysed: Evaluable set of subjects for PK analysis

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Sunitinib in Combination With Docetaxel n = 11
SU011248 C1D2	486.38 (132.439)
SU011248 C2D3	479.80 (128.718)
SU012662 C1D2	82.21 (33.204)
SU012662 C2D3	96.88 (30.513)
Total drug C1D2	568.78 (152.106)
Total drug C2D3	567.43 (145.952)

Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 101.23 (90% CI 82.75 to 123.83)
Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 81.72 (90% CI 62.40 to 107.04)
Sunitinib in Combination With Docetaxel: Ratio of adjusted geometric means: 100.00 (90% CI 82.95 to 120.56)

Population analysed: Evaluable set of subjects for PK analysis

Primary outcome: Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose. Mean (Standard Deviation). Unit: ng*hr/mL

Population analysed: Evaluable set of subjects for PK analysis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib in Combination With Docetaxel	11 of 22 (50%)	21 of 22 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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.

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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.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sunitinib (Sutent) and Taxotere in people with Breast Neoplasms, run by Pfizer at 3 sites in 3 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 2 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 23 Dec 2009. 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 Belgium, Italy, Sweden. 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 23 Dec 2009). 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?

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters (time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose). The study lists 12 primary outcomes in all. 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 NCT00291577.

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 23 Dec 2009.