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Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03032614
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 26, 2017
Last Update Posted : October 10, 2017
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

Brief Summary:
This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.

Condition or disease Intervention/treatment Phase
Breast Cancer Stage IV Ovarian Cancer BRCA1 Mutation BRCA2 Mutation Drug: Carboplatin Drug: Eribulin Drug: Veliparib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency
Estimated Study Start Date : September 30, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Combination of Carboplatin, Eribulin, and Veliparib
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.
Drug: Carboplatin
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.
Other Name: Paraplatin

Drug: Eribulin
Eribulin Mesylate is a synthetic halichondrin analog.
Other Names:
  • Halaven
  • E7389

Drug: Veliparib
Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.
Other Name: ABT-888

Primary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients must have breast and ovarian cancer
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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/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

Exclusion Criteria:

  • 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:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03032614

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Virginia Kaklamani, MD UT Health San Antonio
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Responsible Party: Virginia G. Kaklamani, Clinical Investigator, The University of Texas Health Science Center at San Antonio Identifier: NCT03032614    
Other Study ID Numbers: CTMS#16-0133
17-166H ( Other Identifier: UTHSCSA )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action