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

NCT03032614 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: CTMS#16-013317-166H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer Stage IV; Ovarian Cancer; BRCA1 Mutation; BRCA2 Mutation

Outcome Measures

Primary Outcomes (2)

• 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)

  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 every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year

Study Arms (1)

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.

Drug: Carboplatin; Drug: Eribulin; Drug: Veliparib

Interventions

Carboplatin DRUG

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.

Also known as: Paraplatin

Combination of Carboplatin, Eribulin, and Veliparib

Eribulin DRUG

Eribulin Mesylate is a synthetic halichondrin analog.

Also known as: Halaven, E7389

Combination of Carboplatin, Eribulin, and Veliparib

Veliparib DRUG

Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.

Also known as: ABT-888

Combination of Carboplatin, Eribulin, and Veliparib

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients must have breast and ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Interventions

Carboplatin; eribulin; veliparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Virginia Kaklamani, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 26, 2017
• Study Start: September 30, 2017
• Primary Completion: March 31, 2019
• Study Completion: April 30, 2020
• Last Updated: October 10, 2017

Record last verified: 2017-08