Breast NeoplasmsPhase 1/2NCT00076024

AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

A Phase 1/2 study testing Docetaxel and AG-013736 (axitinib) in people with Breast Neoplasms, run by Pfizer at 54 sites in 8 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Docetaxel and AG-013736 (axitinib)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 174 participants
Where: 54 sitesin 8 countries
Study dates: Feb 2004to Nov 2008
Phase: Phase 1/2
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

Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
Adequate bone marrow, liver, and renal function

Who cannot join

Adjuvant chemotherapy given in the past 12 months
Uncontrolled brain metastases

Trial locations and contacts

54 sites in 8 countries.

Country

City, postcode or hospital

54 sites in 8 countries

United States24 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Berkeley, California, 94704
Pfizer Investigational Site
Boston, Massachusetts, 02118
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Corvallis, Oregon, 97330
Pfizer Investigational Site
Jacksonville, Florida, 32204
Pfizer Investigational Site
Jacksonville, Florida, 32207
Pfizer Investigational Site
Jacksonville, Florida, 32223
Pfizer Investigational Site
Jacksonville Beach, Florida, 32250
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Montebello, California, 90640
Pfizer Investigational Site
Monterey Park, California, 91754
Pfizer Investigational Site
Orange Park, Florida, 32073
Pfizer Investigational Site
Palatka, Florida, 32177
Pfizer Investigational Site
Saint Augustine, Florida, 32086
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Gabriel, California, 91776
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Tucson, Arizona, 85724-5024
Pfizer Investigational Site
Tucson, Arizona, 85724
Pfizer Investigational Site
Whittier, California, 90602
Pfizer Investigational Site
Zion, Illinois, 60099

Other trials in United States

Spain8 sites

Pfizer Investigational Site
Girona, Girona, 17007
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Sabadell, Barcelona, 08208
Pfizer Investigational Site
Valencia, Valencia, 46009
Pfizer Investigational Site
Valencia, Valencia, 46010

Other trials in Spain

Italy6 sites

Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Roma, 00128
Pfizer Investigational Site
Roma, 00135
Pfizer Investigational Site
Roma, 00144
Pfizer Investigational Site
Rozzano (Mi), 20089
Pfizer Investigational Site
Taormina, ME, 98039

Other trials in Italy

Germany5 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Essen, 45122
Pfizer Investigational Site
Frankfurt, 60590
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Hamburg, 22081

Other trials in Germany

United Kingdom4 sites

Pfizer Investigational Site
Nottingham, Nottinghamshire, NG5 1PB
Pfizer Investigational Site
Rickmansworth, Middlesex, HA5 2RN
Pfizer Investigational Site
Sheffield, Yorkshire, S10 2SJ
Pfizer Investigational Site
Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Canada3 sites

Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6

Other trials in Canada

Czechia2 sites

Pfizer Investigational Site
Nový Jičín, 741 01
Pfizer Investigational Site
Prague, 180 00

Other trials in Czechia

India2 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Pune, Maharashtra, 411 004

Other trials in India

About this study

Official title: Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination

The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Conditions: Breast Neoplasms
Being tested: Placebo, Docetaxel, AG-013736 (axitinib)
Keywords: metastatic breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

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

PlaceboDrug
5 mg twice daily [bid] continuous dosing
DocetaxelDrug
Standard of care drug administration
AG-013736 (axitinib)Drug
5mg twice daily [bid] continuous dosing
DocetaxelDrug
Standard of care drug administration

Study groups in NCT00076024
Study group	Role	What they receive
Docetaxel + Placebo	Other	Docetaxel + Placebo Receives: Drug: Placebo; Drug: Docetaxel
Docetaxel + AG-013736	Experimental	Docetaxel + AG-013736 Receives: Drug: AG-013736 (axitinib); Drug: Docetaxel

What is being measured

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

Time to Tumor Progression (TTP)
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Measured: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks

Secondary outcomes (4)

Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)
Percentage of participants with OR based 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. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks
Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)
Percentage of participants with OR based 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. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks
Duration of Response (DR) for Phase 2 (Double-blind)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks
Duration of Response (DR) for Phase 2 (Open-label)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks

Timeline

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

Feb 2004Nov 2008

First posted14 Jan 2004 (estimated)
Study startFeb 2004
Primary completionJan 2007
Study completionNov 2008

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00076024
Sponsor's protocol ID: A4061010
Status last verified: Jun 2012
First submitted: 12 Jan 2004
Last updated: 26 Jun 2012
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

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination
ClinicalTrials.gov ID: NCT00076024
Acronym / sponsor ID: A4061010
Conditions: Breast Neoplasms
Keywords: metastatic breast cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Jan 2007 (actual)
Study completion: Nov 2008 (actual)
First posted: 14 Jan 2004 (estimated)
Results: Posted 16 Mar 2012

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Docetaxel + Placebo	Other	Drug: Placebo, Drug: DocetaxelDocetaxel + Placebo
Docetaxel + AG-013736	Experimental	Drug: AG-013736 (axitinib), Drug: DocetaxelDocetaxel + AG-013736

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)

Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
Adequate bone marrow, liver, and renal function

Key exclusion criteria (2 listed)

Adjuvant chemotherapy given in the past 12 months
Uncontrolled brain metastases

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
Placebo5 mg twice daily [bid] continuous dosing	Drug	Docetaxel + Placebo
DocetaxelStandard of care drug administration	Drug	Docetaxel + Placebo
AG-013736 (axitinib)5mg twice daily [bid] continuous dosing	Drug	Docetaxel + AG-013736
DocetaxelStandard of care drug administration	Drug	Docetaxel + AG-013736

Primary outcome

Time to Tumor Progression (TTP)
Time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

4 secondary outcomes

Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)
Time frame: Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks
Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)
Time frame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks
Duration of Response (DR) for Phase 2 (Double-blind)
Time frame: Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks
Duration of Response (DR) for Phase 2 (Open-label)
Time frame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks

Results and safety

Results posted to the registry on 16 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axitinib + Docetaxel (Phase-1, Lead-in)	6	0
Axitinib + Docetaxel (Phase 2, Double-blind)	0	0
Docetaxel + Placebo (Phase 2, Double-blind)	0	0
Axitinib (Phase 2, Open-label)	0	0

Primary outcome: Time to Tumor Progression (TTP)

Time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks. Median (95% Confidence Interval). Unit: days

Measure	Axitinib + Docetaxel (Phase 2, Double-blind) n = 112	Docetaxel + Placebo (Phase 2, Double-blind) n = 55
Value	247 (208 to 265)	215 (191 to 247)

Axitinib + Docetaxel (Phase 2, Double-blind) vs Docetaxel + Placebo (Phase 2, Double-blind): Hazard Ratio (HR): 1.237 (95% CI 0.819 to 1.867), p = 0.156, Log Rank

Population analysed: Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.

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
Axitinib + Docetaxel (Phase-1 Lead-in)	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Axitinib + Docetaxel (Phase 2, Double-blind)	54 of 111 (48.6%)	111 of 111 (100%)	Not reported
Docetaxel + Placebo (Phase 2, Double-blind)	17 of 56 (30.4%)	56 of 56 (100%)	Not reported
Axitinib (Phase 2, Open-label)	2 of 16 (12.5%)	12 of 16 (75%)	Not reported

Limitations and caveats (from the sponsor): Analysis of TTP (Phase 2, Double-blind) was performed with both discontinuation due to lack of efficacy (LOE) considered a progression and not considered a progression event. Latter was considered primary analysis and former a sensitivity analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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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

54 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docetaxel and AG-013736 (axitinib) in people with Breast Neoplasms, run by Pfizer at 54 sites in 8 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 2 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Spain, Italy, Germany, United Kingdom and 3 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Mar 2012). 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 Tumor Progression (TTP) (time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks). 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 NCT00076024.

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 26 Jun 2012.