Breast Cancer Stage IVPhase 2NCT03032614
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
A Phase 2 study testing Carboplatin, Eribulin and Veliparib in people with Breast Cancer Stage IV and Ovarian Cancer, run by The University of Texas Health Science Center at San Antonio.
Trial summary
This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage IV, Ovarian Cancer, BRCA1 Mutation
- What is being tested?
- Carboplatin, Eribulin and Veliparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2017to 30 Apr 2020
- Phase
- Phase 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
- 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:
Show all 18Show fewer
- Leukocytes ≥ 3,000/uL
- Absolute neutrophil count ≥ 1,500/uL
- Platelets ≥ 100,000/uL
- 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
- Patients must have stage IV breast or stage III and IV ovarian cancer (including platinum sensitive disease)
- 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 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
- Previous systemic treatment is allowed with a 21 day 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 24Show 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 Veliparib, 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 II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency
This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.
Read the detailed description
This is a Phase II, non-randomized, open-label, Clinical Trial on the Combination of Carboplatin, Eribulin, and Veliparib in Patients with BRCA-related Cancers.
- Conditions
- Breast Cancer Stage IV, Ovarian Cancer, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Carboplatin, Eribulin, Veliparib
- Medical subject headings
- Breast Neoplasms, Ovarian 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 is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific.
EribulinDrug
Also called Halaven, E7389
Eribulin Mesylate is a synthetic halichondrin analog.
VeliparibDrug
Also called ABT-888
Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Carboplatin, Eribulin, and Veliparib | Experimental | Eribulin will be administered intravenously (IV) on days 1 and 8 of each cycle at a dose of 1.1 mg/m2 over a 2-5 minute time period; on cycle day 1. Carboplatin will be administered intravenously at a dose of AUC 5 on day 1 of each cycle, over 30 min, immediately following eribulin infusion, per institutional guidelines. Veliparib will be given at 120 mg bid (two times a day), on days 2-12 for the first cycle of the safety run-in period and thereafter at 240 mg bid. Receives: Drug: Carboplatin; Drug: Eribulin; Drug: Veliparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
Graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
Measured: Approximately 1.5 years
Tumor response assessed using RECIST 1.1 guidelines
Response will be assessed in this study via physical exam and imaging.
Measured: Measured every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start30 Sep 2017 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
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 Breast Cancer Stage IVStudies 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 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, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032614
- Sponsor's protocol ID
- CTMS#16-0133
- Other IDs
- 17-166H
- Status last verified
- Aug 2017
- First submitted
- 23 Jan 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency
- ClinicalTrials.gov ID
- NCT03032614
- Acronym / sponsor ID
- CTMS#16-0133
- Conditions
- Breast Cancer Stage IV, Ovarian Cancer, BRCA1 Mutation, BRCA2 Mutation
- Phase
- Phase 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
- 30 Sep 2017 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 26 Jan 2017 (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.
This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.
Detailed description
This is a Phase II, non-randomized, open-label, Clinical Trial on the Combination of Carboplatin, Eribulin, and Veliparib in Patients with BRCA-related Cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Carboplatin, Eribulin, and Veliparib | Experimental | Drug: Carboplatin, Drug: Eribulin, Drug: VeliparibEribulin will be administered intravenously (IV) on days 1 and 8 of each cycle at a dose of 1.1 mg/m2 over a 2-5 minute time period; on cycle day 1. Carboplatin will be administered intravenously at a dose of AUC 5 on day 1 of each cycle, over 30 min, immediately following eribulin infusion, per institutional guidelines. Veliparib will be given at 120 mg bid (two times a day), on days 2-12 for the first cycle of the safety run-in period and thereafter at 240 mg bid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (24 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
- Previous systemic treatment is allowed with a 21 day 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 is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific. | Drug | Combination of Carboplatin, Eribulin, and Veliparib |
| EribulinAlso: Halaven, E7389Eribulin Mesylate is a synthetic halichondrin analog. | Drug | Combination of Carboplatin, Eribulin, and Veliparib |
| VeliparibAlso: ABT-888Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics. | Drug | Combination of Carboplatin, Eribulin, and Veliparib |
Primary outcome
Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
Time frame: Approximately 1.5 years
Graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
Tumor response assessed using RECIST 1.1 guidelines
Time frame: Measured every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year
Response will be assessed in this study via physical exam and imaging.
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 10 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer Stage IV
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, 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
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
Metastatic Breast Cancer, Lobular Breast Carcinoma
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
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, MD principal investigator
The University of Texas Health Science Center at San Antonio
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Eribulin and Veliparib in people with Breast Cancer Stage IV and Ovarian Cancer, 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 18 inclusion and 24 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 10 Oct 2017. 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 phase mean?
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?
Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03) (time frame: Approximately 1.5 years). 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 Oct 2017.