Male Breast CancerPhase 1NCT01084057
Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer
A Phase 1 study testing vorinostat, ixabepilone and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- vorinostat, ixabepilone and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2010to 27 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; stable brain metastasis is allowed (not on anti-seizure or steroids for at least three months); if histological or cytological confirmation is not available/not done, patients who demonstrate metastatic disease as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), or Bone Scan may continue on study, if in the investigators clinical opinion this represents metastatic disease; also, skin disease that has not been biopsied may be used if in the investigators clinical opinion this represents metastatic disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan
- Multiple prior chemotherapy regimens (including trastuzumab containing regimens in human epidermal growth factor receptor 2 [Her-2] positive patients) for metastatic disease are allowed; prior radiation therapy and/or prior hormonal therapy (will need 2 weeks wash out period prior to enrollment) are allowed
- Life expectancy of greater than 6 months
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Hemoglobin >= 9.0 g/dl
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- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Total bilirubin =< 1.0 times upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times the ULN
- Creatinine =< 1.5 times ULN
- The effects of vorinostat and ixabepilone on the developing human fetus at the recommended therapeutic dose are unknown; women of childbearing potential must have a negative serum pregnancy test performed within 7 days of registration; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately and the patient will be withdrawn from the study
- Female patient of childbearing potential is willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with visit 1 through 30 days after the last dose of study drug; adequate contraceptive methods include for example, intra-uterine device, diaphragm with spermicide, cervical cap with spermicide, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
- Male patient agrees to use an adequate method of contraception starting with the first dose of study drug through 30 days after the last dose of study drugs
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had chemotherapy, radiotherapy (must not include >= 30% of major bone marrow containing area) or any systemic anti-cancer drugs within 4 weeks (2 weeks for Hormonal therapy) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks
- Patients may not be receiving any other investigational agents
- Patients with unstable brain metastases (requirement of steroids or active seizures) are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to asses brain metastasis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior ixabepilone and/or vorinostat are not allowed
- Prior valproic acid treatment for epilepsy will need 30 days wash out period prior to enrollment
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- Pregnant women are excluded from this study because of unknown potential teratogenesis
- Human immunodeficiency virus (HIV)-positive patients are ineligible because of the potential for pharmacokinetic interactions with study drugs through the protease inhibition of the cytochrome P450 3A4 (CYP3A4); in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
- Patients with chronic hepatitis B or C are also excluded from this study
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g. ixabepilone, cremaphor)
- Any > grade I neuropathy is contraindicated
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope
Duarte, California, 91010
South Pasadena Cancer Center
South Pasadena, California, 91030
About this study
Official title: Phase I Trial of Ixabepilone and Vorinostat in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of the combination of vorinostat with ixabepilone.
II. To determine the best schedule for delivery of this drug combination. III. To recommend a phase II dose of vorinostat in combination with ixabepilone.
SECONDARY OBJECTIVES:
- To determine the objective response rate and/or clinical benefit rate. II. To assess the toxicity profile.
TERTIARY OBJECTIVES:
- Collecting circulating tumor cells pre and post-treatment to study its deoxyribonucleic acid (DNA) somatic mutation and methylation assay after the introduction of histone deacetylases (HDAC) inhibitors and ixabepilone.
II. To determine whether administration of vorinostat with ixabepilone will alter the pharmacokinetics of vorinostat.
OUTLINE: This is a phase I, dose-escalation study of vorinostat. Patients are randomized to 1 of 2 treatment arms.
Arm I (Cohort A): Patients receive oral vorinostat once daily on days 1-14 and ixabepilone intravenously (IV) over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Cohort B): Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
- Being tested
- vorinostat, ixabepilone, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
Also called L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Given orally
ixabepiloneDrug
Also called Azaepothilone B, BMS-247550, epothilone B lactam, Epothilone-B BMS 247550
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Cohort A) | Experimental | Patients receive oral vorinostat once daily on days 1-14 and ixabepilone IV over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: vorinostat; Drug: ixabepilone; Other: laboratory biomarker analysis; Other: pharmacological study |
| Arm II (Cohort B) | Experimental | Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: vorinostat; Drug: ixabepilone; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity
Graded according to the National Cancer Institute (NCI) CTCAE version 4.0. DLT is defined for each dose level and will include both drugs ixabepilone and vorinostat.
Measured: Cohort A evaluated every 3 weeks during treatment, Cohort B every 4 weeks during treatment.
Secondary outcomes (2)
Objective response rate and/or clinical benefit rate
Measured: Cohort A evaluated every 6 weeks, Cohort B evaluated every 8 weeks until progression of disease.
Toxicity profile
Measured: Cohort A every 3 weeks during treatment, Cohort B every 4 weeks during treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study start2 Jun 2010
- Primary completion12 Nov 2012
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Yuan, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084057
- Sponsor's protocol ID
- 08166
- Other IDs
- NCI-2010-00306
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2010
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Ixabepilone and Vorinostat in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01084057
- Acronym / sponsor ID
- 08166
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2010 (actual)
- Primary completion
- 12 Nov 2012 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 10 Mar 2010 (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.
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of the combination of vorinostat with ixabepilone.
II. To determine the best schedule for delivery of this drug combination. III. To recommend a phase II dose of vorinostat in combination with ixabepilone.
SECONDARY OBJECTIVES:
- To determine the objective response rate and/or clinical benefit rate. II. To assess the toxicity profile.
TERTIARY OBJECTIVES:
- Collecting circulating tumor cells pre and post-treatment to study its deoxyribonucleic acid (DNA) somatic mutation and methylation assay after the introduction of histone deacetylases (HDAC) inhibitors and ixabepilone.
II. To determine whether administration of vorinostat with ixabepilone will alter the pharmacokinetics of vorinostat.
OUTLINE: This is a phase I, dose-escalation study of vorinostat. Patients are randomized to 1 of 2 treatment arms.
Arm I (Cohort A): Patients receive oral vorinostat once daily on days 1-14 and ixabepilone intravenously (IV) over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Cohort B): Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Cohort A) | Experimental | Drug: vorinostat, Drug: ixabepilone, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral vorinostat once daily on days 1-14 and ixabepilone IV over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (Cohort B) | Experimental | Drug: vorinostat, Drug: ixabepilone, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; stable brain metastasis is allowed (not on anti-seizure or steroids for at least three months); if histological or cytological confirmation is not available/not done, patients who demonstrate metastatic disease as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), or Bone Scan may continue on study, if in the investigators clinical opinion this represents metastatic disease; also, skin disease that has not been biopsied may be used if in the investigators clinical opinion this represents metastatic disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan
- Multiple prior chemotherapy regimens (including trastuzumab containing regimens in human epidermal growth factor receptor 2 [Her-2] positive patients) for metastatic disease are allowed; prior radiation therapy and/or prior hormonal therapy (will need 2 weeks wash out period prior to enrollment) are allowed
- Life expectancy of greater than 6 months
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Key exclusion criteria (13 listed)
- Patients who have had chemotherapy, radiotherapy (must not include >= 30% of major bone marrow containing area) or any systemic anti-cancer drugs within 4 weeks (2 weeks for Hormonal therapy) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks
- Patients may not be receiving any other investigational agents
- Patients with unstable brain metastases (requirement of steroids or active seizures) are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to asses brain metastasis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior ixabepilone and/or vorinostat are not allowed
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 |
|---|---|---|
| vorinostatAlso: L-001079038, SAHA, suberoylanilide hydroxamic acid, ZolinzaGiven orally | Drug | Arm I (Cohort A), Arm II (Cohort B) |
| ixabepiloneAlso: Azaepothilone B, BMS-247550, epothilone B lactam, Epothilone-B BMS 247550Given IV | Drug | Arm I (Cohort A), Arm II (Cohort B) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (Cohort A), Arm II (Cohort B) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (Cohort A), Arm II (Cohort B) |
Primary outcome
Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity
Time frame: Cohort A evaluated every 3 weeks during treatment, Cohort B every 4 weeks during treatment.
Graded according to the National Cancer Institute (NCI) CTCAE version 4.0. DLT is defined for each dose level and will include both drugs ixabepilone and vorinostat.
2 secondary outcomes
Objective response rate and/or clinical benefit rate
Time frame: Cohort A evaluated every 6 weeks, Cohort B evaluated every 8 weeks until progression of disease.
Toxicity profile
Time frame: Cohort A every 3 weeks during treatment, Cohort B every 4 weeks during treatment.
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 26 Oct 2026.
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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.
Yuan Yuan, MD, PhD principal investigator
City of Hope Medical Center
2 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 vorinostat, ixabepilone and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
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 15 inclusion and 13 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity (time frame: Cohort A evaluated every 3 weeks during treatment, Cohort B every 4 weeks during treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.