Cancer of the BreastPhase 1/2NCT02396433
Combination of Carboplatin, Eribulin Mesylate, and E7449 in BRCA-Related Cancers
A Phase 1/2 study testing Carboplatin, Eribulin and E7449 in people with Cancer of the Breast, run by The University of Texas Health Science Center at San Antonio.
Trial summary
Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the combination of carboplatin, eribulin, and E7449. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Breast
- What is being tested?
- Carboplatin, Eribulin and E7449
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2015
- 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
- Phase I only
- Patients must have stage IV breast or ovarian cancer or another BRCA mutation-related cancer.
- Patients may have either measurable or evaluable disease per RECIST 1.1 criteria.
- NOTE: Measurable lesions are defined as those 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.
- Patients must be refractory to / intolerant of established therapy known to provide clinical benefit for their condition.
- Both Phase I \& II
Show all 22Show fewer
- Patients must have archival biopsy specimens (preferably from metastatic disease) available for research tests. If a suitable biopsy specimen is not available, patients will be asked to undergo a research biopsy to procure tissue.
- Patients must be ≥ 18 years.
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation
- Patients must have an ECOG performance status 0-1.
- Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment for that cancer.
- Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/μL Absolute neutrophil count ≥ 1,500/μL Platelets ≥ 100,000/μL Creatinine within normal limits or creatinine clearance ≥30
- Patients must be able to swallow and retain oral medication.
- Patients who were receiving prior systemic therapy: Prior treatment related side effects must have resolved to < Grade 2 severity (except alopecia and infertility).
- All patients must have given signed, informed consent prior to registration on study.
- Phase II Only
- Patients must have stage IV breast or ovarian cancer
- Patients must have BRCA1/2 deleterious mutations, PTEN deficiency, or cancer with a high HRD score as assessed by Myriad's assay
- Patients must have measurable disease per RECIST 1.1 criteria (see above for definition).
- Patients may not have received more than 3 chemotherapeutic regimens for metastatic disease.
- Patients who may not have received treatment with prior carboplatin, eribulin or a PARP inhibitor.
Who cannot join
- Women who are pregnant or lactating are not eligible
- Patients who are undergoing concomitant radiotherapy are not eligible.
- Patients who are receiving any other investigational agents or concurrent anticancer therapy are not eligible.
- NOTE: Previous systemic treatment is allowed with a 14 day (Phase I) or 21 day (Phase II) washout period prior to registration.
- Patients who are taking any herbal (alternative) medicines are not eligible. Patients must be off any such medications by the time of registration.
- Patients with known brain metastases are not eligible for participation unless the following are met:
Show all 13Show fewer
- Brain metastases are treated (either with surgical excision, stereotactic radiosurgery or radiotherapy and have been stable for at least 4 weeks (MRI documented) Patient is asymptomatic and has discontinued corticosteroids if taken for that purpose
- Patients with any of the following conditions or complications are NOT eligible for participation:
- GI tract disease resulting in an inability to take oral medication Malabsorption syndrome Require IV alimentation History of prior surgical procedures affecting absorption Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis). Hypersensitivity of any of the components of E7449, carboplatin, eribulin History of significant neurological (no neuropathy > Grade 2) or psychiatric disorders.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
- Significant non-neoplastic renal disease. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
- Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder) i.e., requiring relevant changes in medication within the last month or hospital admission within the last three months Active infection requiring systemic therapy. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.
- Prolongation of QTc interval to > 480 msec when electrolytes balance is normal. Major surgery within 4 weeks prior to the first dose of study drug
About this study
Official title: Phase I/II Clinical Trial of the Combination of Carboplatin, Eribulin Mesylate, and E7449 in Patients With BRCA-Related Cancers
Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the combination of carboplatin, eribulin, and E7449.
Read the detailed description
This is a phase I/II clinical trial of the combination of carboplatin, eribulin, and E7449. A cycle will be defined as 21 days. Carboplatin will be given on day 1 of each cycle. Eribulin will be given on days 1 and 8 of each cycle. E7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects.
- Conditions
- Cancer of the Breast
- Being tested
- Carboplatin, Eribulin, E7449
- Keywords
- Halaven, BRCA, E7449
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin
Carboplatin will be given on day 1 of each cycle.
EribulinDrug
Also called Halaven
Eribulin will be given on days 1 and 8 of each cycle.
E7449Drug
Also called PARP inhibitor
E7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin, eribulin, and E7449 | Experimental | This is a phase I/II clinical trial of the combination of carboplatin, eribulin, and E7449. Receives: Drug: Carboplatin; Drug: Eribulin; Drug: E7449 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of E7449 will be measured by the number, frequency and severity of adverse events.
Patients will be evaluated by MD at clinic visits during Cycle 1, on Day 1 of all 21-day cycles, and will have additional evaluations if clinically indicated.
Measured: Baseline to 24 months
MTD (maximum tolerated dose) of E7449 will be measured by the number, frequency and severity of adverse events.
Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of non-hematologic DLT (dose limiting toxicity) is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v 4.03 criteria.
Measured: Baseline to 21 days
Secondary outcomes (1)
Overall response rate will be measured by the evaluation of target and non-target lesions for changes in tumor measurements.
The overall response rate (ORR) will be defined as response after scans (CT or MRI) assessed after two cycles of therapy (1 cycle = 3 weeks).
Measured: Baseline to first occurrence of disease progression or death. (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the BreastStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio
- Investigators
- Virginia Kaklamani, Principal investigator, UTHSCSA@CTRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396433
- Sponsor's protocol ID
- CTMS# 14-2024
- Status last verified
- Aug 2015
- First submitted
- 10 Feb 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of the Combination of Carboplatin, Eribulin Mesylate, and E7449 in Patients With BRCA-Related Cancers
- ClinicalTrials.gov ID
- NCT02396433
- Acronym / sponsor ID
- CTMS# 14-2024
- Conditions
- Cancer of the Breast
- Keywords
- Halaven, BRCA, E7449
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Mar 2015 (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.
Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the combination of carboplatin, eribulin, and E7449.
Detailed description
This is a phase I/II clinical trial of the combination of carboplatin, eribulin, and E7449. A cycle will be defined as 21 days. Carboplatin will be given on day 1 of each cycle. Eribulin will be given on days 1 and 8 of each cycle. E7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin, eribulin, and E7449 | Experimental | Drug: Carboplatin, Drug: Eribulin, Drug: E7449This is a phase I/II clinical trial of the combination of carboplatin, eribulin, and E7449. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Phase I only
- Patients must have stage IV breast or ovarian cancer or another BRCA mutation-related cancer.
- Patients may have either measurable or evaluable disease per RECIST 1.1 criteria.
- NOTE: Measurable lesions are defined as those 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.
- Patients must be refractory to / intolerant of established therapy known to provide clinical benefit for their condition.
Key exclusion criteria (13 listed)
- Women who are pregnant or lactating are not eligible
- Patients who are undergoing concomitant radiotherapy are not eligible.
- Patients who are receiving any other investigational agents or concurrent anticancer therapy are not eligible.
- NOTE: Previous systemic treatment is allowed with a 14 day (Phase I) or 21 day (Phase II) washout period prior to registration.
- Patients who are taking any herbal (alternative) medicines are not eligible. Patients must be off any such medications by the time of registration.
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 |
|---|---|---|
| CarboplatinAlso: ParaplatinCarboplatin will be given on day 1 of each cycle. | Drug | Carboplatin, eribulin, and E7449 |
| EribulinAlso: HalavenEribulin will be given on days 1 and 8 of each cycle. | Drug | Carboplatin, eribulin, and E7449 |
| E7449Also: PARP inhibitorE7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects. | Drug | Carboplatin, eribulin, and E7449 |
Primary outcome
Safety of E7449 will be measured by the number, frequency and severity of adverse events.
Time frame: Baseline to 24 months
Patients will be evaluated by MD at clinic visits during Cycle 1, on Day 1 of all 21-day cycles, and will have additional evaluations if clinically indicated.
MTD (maximum tolerated dose) of E7449 will be measured by the number, frequency and severity of adverse events.
Time frame: Baseline to 21 days
Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of non-hematologic DLT (dose limiting toxicity) is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v 4.03 criteria.
1 secondary outcome
Overall response rate will be measured by the evaluation of target and non-target lesions for changes in tumor measurements.
Time frame: Baseline to first occurrence of disease progression or death. (up to 6 weeks)
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 25 Aug 2015.
Related trials for Cancer of the Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Virginia Kaklamani principal investigator
UTHSCSA@CTRC
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carboplatin, Eribulin and E7449 in people with Cancer of the Breast, run by The University of Texas Health Science Center at San Antonio.
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 22 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: withdrawn, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety of E7449 will be measured by the number, frequency and severity of adverse events. (time frame: Baseline to 24 months). 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 25 Aug 2015.