Locally Advanced or Metastatic Breast CancerPhase 1NCT00634088
Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
A Phase 1 study testing Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg, Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg and Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg in people with Locally Advanced or Metastatic Breast Cancer, run by R-Pharm at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg, Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg and Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
- Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
- Positive status for human epidermal growth factor receptor 2
- Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
- Karnofsky performance status of 70 to 100
- Life expectancy of at least 3 months
Who cannot join
- Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
- Common Terminology Criteria Grade 2 or greater neuropathy
- Inadequate hematologic, hepatic, or renal function
- Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
- Known or suspected dihydropyrimidine dehydrogenase deficiency
- More than 3 prior chemotherapy regimens in the metastatic setting
- Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.
- Being tested
- Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg, Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg, Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg, Ixabepilone + Lapatinib + Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mgDrug
Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle.
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mgDrug
Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle.
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mgDrug
Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle.
Ixabepilone + Lapatinib + CapecitabineDrug
Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg | Experimental | Dose Level 1 Receives: Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg |
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg | Experimental | Dose Level 2 Receives: Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg |
| Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg | Experimental | Dose Level 3 Receives: Drug: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg |
| Ixabepilone + Lapatinib + Capecitabine | Experimental | Triplet Combination Receives: Drug: Ixabepilone + Lapatinib + Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib
The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
Measured: Days 1 through 21
MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine
MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
Measured: Days 1 through 21
Secondary outcomes (11)
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)
AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.
Measured: Baseline to Day 21, continuously
Number of Participants With DLT
DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.
Measured: Baseline to Day 21, continuously
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade
CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
Measured: Baseline and weekly from Days 1 to 21 (Cycle 1)
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade
CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN-2.5*ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN-2.5* ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN-2.5*ULN, Gr 2:>2.5-5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-10.0*ULN, Gr 4:>10.0*ULN
Measured: At baseline and within 72 hours of Day 1 of 21-day cycle
Maximum Concentration of Ixabepilone
Measured: Day 1 of 21-day cycle
Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone
Measured: Day 1 of 21-day cycle
Terminal Half-life of Ixabepilone
Measured: Day 1 of 21-day cycle
Time to Peak Concentration of Ixabepilone
Measured: Day 1 of 21-day cycle
Volume of Distribution at Steady State of Ixabepilone
Measured: Day 1 of 21-day cycle
Overall Tumor Response By Number of Participants
Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.
Measured: Baseline and Day 21 (21-day cycle)
Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib
Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
Measured: First occurrence of PR or CR to PD or Death (no average, as no data available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Slow Accrual
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 Locally Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634088
- Sponsor's protocol ID
- CA163-144
- Other IDs
- EURDRACT: 2007-004123-38
- Status last verified
- Feb 2016
- First submitted
- 5 Mar 2008
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00634088
- Acronym / sponsor ID
- CA163-144
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 3 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg | Experimental | Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mgDose Level 1 |
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg | Experimental | Drug: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mgDose Level 2 |
| Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg | Experimental | Drug: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mgDose Level 3 |
| Ixabepilone + Lapatinib + Capecitabine | Experimental | Drug: Ixabepilone + Lapatinib + CapecitabineTriplet Combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
- Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
- Positive status for human epidermal growth factor receptor 2
- Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
- Karnofsky performance status of 70 to 100
Key exclusion criteria (7 listed)
- Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
- Common Terminology Criteria Grade 2 or greater neuropathy
- Inadequate hematologic, hepatic, or renal function
- Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
- Known or suspected dihydropyrimidine dehydrogenase deficiency
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 |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mgLapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle. | Drug | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg |
| Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mgInitiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle. | Drug | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg |
| Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mgInitiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle. | Drug | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg |
| Ixabepilone + Lapatinib + CapecitabinePlanned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study. | Drug | Ixabepilone + Lapatinib + Capecitabine |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib
Time frame: Days 1 through 21
The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine
Time frame: Days 1 through 21
MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
11 secondary outcomes
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)
Time frame: Baseline to Day 21, continuously
Number of Participants With DLT
Time frame: Baseline to Day 21, continuously
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade
Time frame: Baseline and weekly from Days 1 to 21 (Cycle 1)
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade
Time frame: At baseline and within 72 hours of Day 1 of 21-day cycle
Maximum Concentration of Ixabepilone
Time frame: Day 1 of 21-day cycle
Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone
Time frame: Day 1 of 21-day cycle
Terminal Half-life of Ixabepilone
Time frame: Day 1 of 21-day cycle
Time to Peak Concentration of Ixabepilone
Time frame: Day 1 of 21-day cycle
Volume of Distribution at Steady State of Ixabepilone
Time frame: Day 1 of 21-day cycle
Overall Tumor Response By Number of Participants
Time frame: Baseline and Day 21 (21-day cycle)
Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib
Time frame: First occurrence of PR or CR to PD or Death (no average, as no data available)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Locally Advanced or Metastatic Breast Cancer
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg, Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg and Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg in people with Locally Advanced or Metastatic Breast Cancer, run by R-Pharm 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Mar 2016. 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 United States, Australia, Italy. 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 3 May 2011). 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?
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib (time frame: Days 1 through 21). The study lists 2 primary outcomes in all. 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 10 Mar 2016.