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Trial record 11 of 157 for:    eribulin

PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

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.
ClinicalTrials.gov Identifier: NCT02864030
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Oncologia Medica dell'Ospedale Fatebenefratelli

Brief Summary:

On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease.

As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted.

Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Toxicity Neurotoxicity Drug Toxicity Adverse Drug Event Drug: ERIBULIN MESYLATE Phase 4

Detailed Description:

This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with metastatic breast cancer in relation to toxicities already described in clinical trials, and neurotoxicity in particular.

The secondary objectives of this trial include:

  • To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy
  • To describe treatment efficacy in terms of duration of treatment and impact on survival.

All toxicities will be collected and classified according to National Cancer Institute Common Terminology criteria for Adverse Events (NCI CTCAE) version 4.0 and monitored during all the treatment period and up to 30 days after therapy discontinuation.

In particular, evaluation of incidence and outcome of any grade AEs already recorded in previous clinical trials will be collected, as follows:

  • asthenia/fatigue,
  • neutropenia,
  • alopecia,
  • nausea,
  • peripheral neuropathy
  • constipation

Any other unexpected AEs shall be evaluated likewise.

Patients must be followed for AEs until every ongoing Eribulin-related/unrelated toxicity and AE have been resolved, or the Investigator assesses them as "chronic" or "stable" or until the end of the trial, whichever comes first. For patients who will begin a new anticancer therapy after the last study drug administration, the AEs reporting period will end at the time the new treatment starts.

For the determination of polymorphisms, a routine blood collection of two tubes with 3-5 ml of blood be performed. The sample can be collected at any time during the participant's first two treatment cycles. Blood will be collected in a Vacutainer containing ethylendiaminetetraacetic acid (EDTA). Immediately after blood collection, tubes have to be inverted (at least five times) and then stored at - 20° C.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multicenter, Interventional, Single-arm, Phase IV Study Evaluating Tolerability of Eribulin and Its Relationship With a Set of Polymorphisms in an Unselected Population of Female Patients With Metastatic Breast Cancer
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single arm with Eribulin mesylate Drug: ERIBULIN MESYLATE

Eribulin mesylate will be administered according to the European Medicines Agency (EMA) and Italian Medicines Agency (AIFA) approved indications and schedule consists in 1.23 mg/m2 on day 1 and on day 8 of each cycle. Cycles will be repeated every 21 days until progression of disease, unacceptable toxicity, patient refusal or medical decision.

The decision to treat patients with Eribulin is independent from the trial. Patients will be treated and managed according to clinical practice. The physician can choose any further line of treatment after disease progression with Eribulin.

Other Name: HALAVEN




Primary Outcome Measures :
  1. Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade) [ Time Frame: Trough study completion, an average of 1 year ]
    All toxicities and their grade will be reported according to Common Terminology criteria for Adverse Events (CTCAE) v4.0, especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.

  2. Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy [ Time Frame: Trough study completion, an average of 1 year ]
    The association between a set of selected polymorphisms and the onset of all grades peripheral neuropathy will be investigated using blood samples collected at the time of treatment initiation.

  3. Treatment tolerability [ Time Frame: Trough study completion, an average of 1 year ]
    Treatment tolerability will also be described in terms of dose intensity and dose schedule maintenance.

  4. DOT (Duration Of Treatment) [ Time Frame: Trough study completion, an average of 1 year ]
    DOT will be calculated for each patient from the date of start of Eribulin treatment to the date of last Eribulin administration for any cause (i.e. progression of disease, unacceptable toxicity, patient refusal or physician decision).

  5. OS (Overall Survival) [ Time Frame: Trough study completion, an average of 1 year ]
    OS will be calculated from the date of start of therapy to the date of death.


Other Outcome Measures:
  1. The European Organization for research and treatment of cancer Quality of Life Questionnaire EORTC QLQ - C30 [ Time Frame: Trough study completion, an average of 1 year ]
    This is a kind of assessment to evaluate the quality of life of cancer patients during Eribulin treatment using unique measurements that share a common Unit of Measure

  2. Breast Cancer-Specific Quality of Life Questionnaire QlQ - BR23 [ Time Frame: Trough study completion, an average of 1 year ]
    This is a kind of assessment to evaluate the quality of life during Eribulin treatment using unique measurements that share a common Unit of Measure



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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of metastatic breast cancer
  • Previous treatment with anthracyclines and taxanes
  • Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
  • Ability to comply with sample collection
  • Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
  • Absence of any contraindication to treatment

Exclusion Criteria:

  • Previous treatment with Eribulin in a previous line of treatment
  • Previous treatment with Eribulin off label

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 ClinicalTrials.gov identifier (NCT number): NCT02864030


Locations
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Italy
Comprensorio sanitario di Bolzano
Bolzano, Italy, 39100
Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy, 12100
A.O.U. Careggi
Firenze, Italy, 50134
A.O. Vito Fazzi
Lecce, Italy, 73100
Ospedale Civile di Legnano
Legnano, Italy, 20025
Oncologia Medica Ospedale Fatebenefratelli
Milano, Italy, 20121
ASL Salerno Presidio Ospedaliero Andrea Tortora
Pagani, Italy, 84016
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy, 27100
Azienda Ospedaliera di Piacenza
Piacenza, Italy, 29100
POliclinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Fondazione Policlinico Tor Vergata
Roma, Italy, 00133
Istituto Nazionale Tumori "Regina Elena" Oncologia Medica A
Roma, Italy, 00144
Istituto Nazionale Tumori "Regina Elena" Oncologia medica B
Roma, Italy, 00144
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Azienda Ospedaliera Valtellina e Valchiavenna - Presidio di Sondrio
Sondrio, Italy, 23100
ASL di FRosinone Ospedale SS Trinità di Sora
Sora, Italy, 03039
A.O. Santa Maria di Terni
Terni, Italy, 5100
Ospedale di Treviglio
Treviglio, Italy, 24047
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, Italy, 33100
Sponsors and Collaborators
Oncologia Medica dell'Ospedale Fatebenefratelli
Mario Negri Institute for Pharmacological Research
Investigators
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Study Chair: Laboratory of Clinical Research Department of Oncology IRCCS Istituto Di Ricerche Farmacologiche Mario Negri
Study Chair: Giovanna Damia, PHD Istituto Di Ricerche Farmacologiche Mario Negri

Publications:

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Responsible Party: Oncologia Medica dell'Ospedale Fatebenefratelli
ClinicalTrials.gov Identifier: NCT02864030     History of Changes
Other Study ID Numbers: PAINTER01
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oncologia Medica dell'Ospedale Fatebenefratelli:
Eribulin mesylate
Halaven
Polymorphisms
Tolerability

Additional relevant MeSH terms:
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Breast Neoplasms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders