Breast CancerPhase 1/2NCT01349088
Investigational Drug in Combination With Two Chemotherapy Drugs in Women With Locally Recurrent or Metastatic Breast Cancer
A Phase 1/2 study testing Ixabepilone, Capecitabine and Motesanib in people with Breast Cancer and Metastatic Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United States. The development of new treatment strategies is essential to improve outcome for patients with metastatic breast cancer There is significant preclinical and clinical evidence indicating that creating new blood vessels… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- Ixabepilone, Capecitabine and Motesanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2018
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the breast regardless of ER, PR and Her2 status with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease.
- Patients with hormone-sensitive tumors must have received prior hormonal therapy and not be amenable to further hormonal therapy.
- Patients with HER2/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) and/or lapatinib (Tykerb®) in the adjuvant or metastatic setting (unless contraindicated) and have progressed while on treatment of metastatic disease or within 12 months of completion of adjuvant therapy.
- Patients will eligible if they have tumors that express one of the motesanib-directed tyrosine kinase markers, the target markers:(PDGFR, VEGFR, c-Kit) as determined by study pathologist. Immunohistochemical assays for these markers are provided by grant consortium partner and CLIA-certified diagnostics laboratory MDRG.
- Measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines.
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- Complete radiology and tumor measurement within 4 weeks (28 days) prior to enrollment.
- Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated.
- Abdomen: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
- Pelvis: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
- Brain: CT scan or MRI
- Bone: Whole body Bone Scintigraphy or PET scan
- Female 18 years of age or older at the time the written informed consent is obtained.
- ECOG Performance Status of 0 or 1.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 2 weeks (14 days) of study enrollment, unless stated otherwise:
- Cardiac function, as follows:
- Normal sinus rhythm (no significant ECG changes)
- Left ventricular ejection fraction ≥ Lower Limit of Normal, as determined by echocardiogram or MUGA scan, according to institutional standards within 28 days prior to study enrollment.
- Hematological function, as follows:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L
- Hemoglobin ≥ 9 g/dL.
- PTT and INR < 1.5 x ULN.
- Renal function, as follows:
- Serum creatinine ≤ 175 µmol/L (= 2mg/dL). If creatinine is between 140-175 µmol/L, creatinine clearance (calculated or measured) should be > 40 mL/min.
- Urinary protein quantitative value of ≤ 30 mg/dL in urinalysis or ≤ 1 + on dipstick unless protein is < 500 mg in a 24-hour urine sample.
- Hepatic function, as follows:
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Total bilirubin ≤ 1 x ULN
- Patients of child-bearing potential and sexually active must provide a negative pregnancy test within 7 days prior to enrollment.
- More than 4 weeks since prior therapy for breast cancer
- No other concurrent investigational or commercial agents or therapies for metastatic breast cancer
- No prior capecitabine or fluorouracil for metastatic breast cancer
- More than 4 weeks since prior radiotherapy Previously irradiated area(s) must not be the only site of disease
- More than 4 weeks since prior major surgery
Who cannot join
- Disease Related:
- Current or prior history of central nervous system metastasis.
- Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 peripheral neuropathy ≥ grade 2 at enrollment.
- Average systolic blood pressure > 150 mm Hg or average diastolic blood pressure > 90 mm Hg (average blood pressure of the 3 separate blood pressure values measured according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
- History of arterial or venous thrombosis within 1 year prior to enrollment.
- History of bleeding diathesis or bleeding within 14 days of enrollment.
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- Major surgical procedure within 4 weeks (28 days) prior to enrollment.
- Minor surgical procedure, placement of access device, or fine needle aspiration within 7 days of enrollment.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or malignancy (other than in situ cervical cancer, or basal cell cancer of the skin), unless treated with curative intent and without evidence of disease for ≥ 3 years before study enrollment.
- Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade II or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.
- Non-healing wound, ulcer or fracture.
- Ongoing or active infection.
- Known chronic hepatitis.
- Medications:
- Currently or previously treated with small molecule inhibitors of VEGF including, but not limited to, SU11248 (sunitinib), PTK787 (vatalinib), AZD 2171, AZD 6474, AEE-788, BAY 43-9006 (sorafenib) and motesanib.
- Treatment with rifampin, carbamazepine, rifabutin or phenobarbital within 14 days prior to study enrollment.
- Treatment with strong CYP 3A inhibitors or inducers such as ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, nefazodone, or any HIV protease inhibitors within 7 days prior to study enrollment.
- Treatment with immune modulators such as cyclosporine and tacrolimus within 7 days prior to study enrollment.
- Treatment with herbal medications containing St. John's Wort within 7 days prior to study enrollment.
- Concomitant therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMS), given for breast cancer prevention or for osteoporosis. Patients must have discontinued these agents prior to enrollment.
- General:
- Known hypersensitivity to any study medications (motesanib, and Chinese Hamster Ovary cell products or other human or humanized recombinant proteins) or Cremaphor.
- Any condition which in the investigator's opinion makes the patient unsuitable for the study participation. This includes substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Participation in other investigational device drug trials, or administration of other investigational treatments within 30 days prior to study enrollment.
- Pregnant (i.e., positive beta-human chorionic gonadotropin test)
- Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), such as nonhormonal IUD, condoms, sexual abstinence or vasectomised partner.
- Contraception must be used during the study and for 6 months after last dose of study treatment
- Unable to swallow oral medications.
- Inability to comply with protocol and/or not available for follow-up assessments.
- Males of any age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase I/II Trial of Motesanib in Combination With Ixabepilone and Capecitabine in Women With Locally Recurrent or Metastatic Breast Cancer
In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United States. The development of new treatment strategies is essential to improve outcome for patients with metastatic breast cancer
There is significant preclinical and clinical evidence indicating that creating new blood vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer, provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor (VEGF) is one of the important molecules regulating new blood vessel formations and subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial interest for the treatment of advanced diseases.
This study will further the body of research of motesanib which has been shown in preclinical pharmacology and clinical pharmacology studies to be a potent, orally bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit receptors.
Read the detailed description
Endocrine therapy and chemotherapy (using either sequential single agents or combination regimens) remain the principal treatments for women with metastatic breast cancer. A wide variety of classes of chemotherapeutic agents have demonstrated anti-tumor activity as single agents or in combination regimens. Cytotoxic chemotherapeutic agents have been the mainstay of cancer therapies for many years and have improved survival in many disease settings. Median survivals remain approximately two years for women with metastatic breast cancer, and less than 3% of patients experience long-term survival after initiation of treatment. The development of new treatment strategies is therefore essential to improve outcome for patients with metastatic breast cancer.
One of the most promising pathways for the development of new anti-neoplastic agents is targeting tumor vascular endothelium. There is significant preclinical and clinical evidence indicating that tumor neoangiogenesis is critical in pathogenesis and progression of solid tumors, including breast cancer. Of the numerous known growth factors that have been implicated in tumor angiogenesis, vascular endothelial growth factor (VEGF) is one of the important molecules regulating new blood vessel formations and subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial interest for the treatment of advanced diseases. More thorough elucidation of mechanisms behind intrinsic and acquired resistance therefore is imperative disease and to identify patients most likely to benefit from treatment options.
Motesanib has been shown in preclinical pharmacology and PK studies to be a potent, orally bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors. It has an acceptable safety profile in both non-clinical and clinical studies, and a PK profile that appears suitable for daily oral dosing in humans.
The investigational product motesanib (Amgen) is a small molecule tyrosine kinase inhibitor with high efficacy against VEGFR and c-Kit kinases. C-kit has been detected in 12% of breast cancers, correlating with basal or triple-negative breast cancer. In addition, efficacy of the drug has been noted to PDGFRα, which is expressed in approximately 40% of breast cancers and is associated with aggressive disease, metastatic invasion and poor prognosis. Importantly, in more than half (56%) of these cases, the carcinoma cells bearing the receptors expressed the PDGF-A ligand, suggesting an autocrine loop and a cancer cell-autonomous process. Cancer cell-autonomous pathways are especially attractive as drug targets against metastatic breast cancer because they are expected to continue to be functional at metastatic sites, since they do not depend on stromal factors.
The primary molecular target of motesanib, VEGFR, is intriguing because neovascularization is expected to be required also at metastatic sites. A preliminary analysis revealed that VEGF expression correlated with the triple-negative, basal breast cancer subtype and poor outcome. Importantly, PDGF receptors are also present on vascular pericytes, cells required for adequate vascularization. Thus, motesanib is a unique multikinase inhibitor that targets both growth factor receptors on the carcinoma cells and growth factor receptors related to neovascularization.
- Being tested
- Ixabepilone, Capecitabine, Motesanib
- Keywords
- breast cancer, metastatic breast cancer, stage IV breast cancer, motesanib, ixabepilone, 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.
IxabepiloneDrug
Also called azaepothilone B, BMS-247550
Patients will receive ixabepilone at 40 mg/m2.
CapecitabineDrug
Also called Xeloda
Patients will receive capecitabine at 2000 mg/m2.
MotesanibDrug
Also called Motesanib diphosphate, AMG 706
Patient will receive motesanib at 100mg or 125mg once daily dependent on outcome of Phase I, which will involve the first 3-6 patients.
| Study group | Role | What they receive |
|---|---|---|
| Motesanib | Experimental | Eligible patients will be enrolled to receive ixabepilone, capecitabine, plus motesanib. Receives: Drug: Ixabepilone; Drug: Capecitabine; Drug: Motesanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-free survival (PFS) is defined as the time from the date of enrollment to the first occurrence of having documented disease progression or death due to any cause. Evaluation of target lesions and non-target lesions will be in accordance with the RECIST criteria.
During the study, assessments of tumor response will take place every 6 weeks. Confirmation of objective response, when applicable, must be performed at a minimum of 4 weeks after the first response has been recorded.
Measured: Up to 3 years or disease progression
Secondary outcomes (5)
Maximum Tolerated Dose of Motesanib
Maximum tolerated dose (MTD) of Motesanib to be determined in the first 3-6 patients enrolled to study (Phase I portion).
Measured: 120 days
Overall Response Rate
The best overall response in an individual patient according to the RECIST criteria is the best response recorded from the time of study entry till disease progression/recurrence. The patient's overall best response can be complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Patients with CR or PR are deemed as responders. Patients with no tumor assessment after the study entry are to be considered as non-responders.
Measured: Through 28 days post-treatment
Toxicity
To determine the toxicity of motesanib, ixabepilone, and capecitabine, using a single arm design trial.
Measured: Through 28 days post-treatment
Correlation of Tumor Levels
To correlate quantitative tumor levels of motesanib-relevant markers PDGFR, VEGFR, C-Kit, and their ligands with response, survival, and time to disease progression in patients treated on this regimen.
Measured: Up to 3 years or disease progression
Pharmacokinetics of Study Regimen
To investigate the pharmacokinetics of motesanib (Cmin), ixabepilone (concentration at the end of infusion), and capecitabine in the combination therapy.
Measured: Through 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startDec 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Amgen
- Responsible party
- Sponsor
- Investigators
- Edith Mitchell, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349088
- Sponsor's protocol ID
- 10G.30
- Other IDs
- 2009-34, JT 1502
- Status last verified
- May 2025
- First submitted
- 4 May 2011
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Motesanib in Combination With Ixabepilone and Capecitabine in Women With Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01349088
- Acronym / sponsor ID
- 10G.30
- Keywords
- breast cancer, metastatic breast cancer, stage IV breast cancer, motesanib, ixabepilone, capecitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Amgen
- Study start
- Dec 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 6 May 2011 (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.
In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United States. The development of new treatment strategies is essential to improve outcome for patients with metastatic breast cancer
There is significant preclinical and clinical evidence indicating that creating new blood vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer, provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor (VEGF) is one of the important molecules regulating new blood vessel formations and subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial interest for the treatment of advanced diseases.
This study will further the body of research of motesanib which has been shown in preclinical pharmacology and clinical pharmacology studies to be a potent, orally bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit receptors.
Detailed description
Endocrine therapy and chemotherapy (using either sequential single agents or combination regimens) remain the principal treatments for women with metastatic breast cancer. A wide variety of classes of chemotherapeutic agents have demonstrated anti-tumor activity as single agents or in combination regimens. Cytotoxic chemotherapeutic agents have been the mainstay of cancer therapies for many years and have improved survival in many disease settings. Median survivals remain approximately two years for women with metastatic breast cancer, and less than 3% of patients experience long-term survival after initiation of treatment. The development of new treatment strategies is therefore essential to improve outcome for patients with metastatic breast cancer.
One of the most promising pathways for the development of new anti-neoplastic agents is targeting tumor vascular endothelium. There is significant preclinical and clinical evidence indicating that tumor neoangiogenesis is critical in pathogenesis and progression of solid tumors, including breast cancer. Of the numerous known growth factors that have been implicated in tumor angiogenesis, vascular endothelial growth factor (VEGF) is one of the important molecules regulating new blood vessel formations and subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial interest for the treatment of advanced diseases. More thorough elucidation of mechanisms behind intrinsic and acquired resistance therefore is imperative disease and to identify patients most likely to benefit from treatment options.
Motesanib has been shown in preclinical pharmacology and PK studies to be a potent, orally bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors. It has an acceptable safety profile in both non-clinical and clinical studies, and a PK profile that appears suitable for daily oral dosing in humans.
The investigational product motesanib (Amgen) is a small molecule tyrosine kinase inhibitor with high efficacy against VEGFR and c-Kit kinases. C-kit has been detected in 12% of breast cancers, correlating with basal or triple-negative breast cancer. In addition, efficacy of the drug has been noted to PDGFRα, which is expressed in approximately 40% of breast cancers and is associated with aggressive disease, metastatic invasion and poor prognosis. Importantly, in more than half (56%) of these cases, the carcinoma cells bearing the receptors expressed the PDGF-A ligand, suggesting an autocrine loop and a cancer cell-autonomous process. Cancer cell-autonomous pathways are especially attractive as drug targets against metastatic breast cancer because they are expected to continue to be functional at metastatic sites, since they do not depend on stromal factors.
The primary molecular target of motesanib, VEGFR, is intriguing because neovascularization is expected to be required also at metastatic sites. A preliminary analysis revealed that VEGF expression correlated with the triple-negative, basal breast cancer subtype and poor outcome. Importantly, PDGF receptors are also present on vascular pericytes, cells required for adequate vascularization. Thus, motesanib is a unique multikinase inhibitor that targets both growth factor receptors on the carcinoma cells and growth factor receptors related to neovascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motesanib | Experimental | Drug: Ixabepilone, Drug: Capecitabine, Drug: MotesanibEligible patients will be enrolled to receive ixabepilone, capecitabine, plus motesanib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast regardless of ER, PR and Her2 status with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease.
- Patients with hormone-sensitive tumors must have received prior hormonal therapy and not be amenable to further hormonal therapy.
- Patients with HER2/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) and/or lapatinib (Tykerb®) in the adjuvant or metastatic setting (unless contraindicated) and have progressed while on treatment of metastatic disease or within 12 months of completion of adjuvant therapy.
- Patients will eligible if they have tumors that express one of the motesanib-directed tyrosine kinase markers, the target markers:(PDGFR, VEGFR, c-Kit) as determined by study pathologist. Immunohistochemical assays for these markers are provided by grant consortium partner and CLIA-certified diagnostics laboratory MDRG.
Key exclusion criteria (30 listed)
- Current or prior history of central nervous system metastasis.
- Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 peripheral neuropathy ≥ grade 2 at enrollment.
- Average systolic blood pressure > 150 mm Hg or average diastolic blood pressure > 90 mm Hg (average blood pressure of the 3 separate blood pressure values measured according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
- History of arterial or venous thrombosis within 1 year prior to enrollment.
- History of bleeding diathesis or bleeding within 14 days of enrollment.
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 |
|---|---|---|
| IxabepiloneAlso: azaepothilone B, BMS-247550Patients will receive ixabepilone at 40 mg/m2. | Drug | Motesanib |
| CapecitabineAlso: XelodaPatients will receive capecitabine at 2000 mg/m2. | Drug | Motesanib |
| MotesanibAlso: Motesanib diphosphate, AMG 706Patient will receive motesanib at 100mg or 125mg once daily dependent on outcome of Phase I, which will involve the first 3-6 patients. | Drug | Motesanib |
Primary outcome
Progression-Free Survival
Time frame: Up to 3 years or disease progression
Progression-free survival (PFS) is defined as the time from the date of enrollment to the first occurrence of having documented disease progression or death due to any cause. Evaluation of target lesions and non-target lesions will be in accordance with the RECIST criteria. During the study, assessments of tumor response will take place every 6 weeks. Confirmation of objective response, when applicable, must be performed at a minimum of 4 weeks after the first response has been recorded.
5 secondary outcomes
Maximum Tolerated Dose of Motesanib
Time frame: 120 days
Overall Response Rate
Time frame: Through 28 days post-treatment
Toxicity
Time frame: Through 28 days post-treatment
Correlation of Tumor Levels
Time frame: Up to 3 years or disease progression
Pharmacokinetics of Study Regimen
Time frame: Through 28 days post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink 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.
Edith Mitchell, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ixabepilone, Capecitabine and Motesanib in people with Breast Cancer and Metastatic Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site 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 36 inclusion and 30 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: withdrawn, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-Free Survival (time frame: Up to 3 years or disease progression). 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 2 May 2025.