INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer (INOVATYON)

February 8, 2022 updated by: Mario Negri Institute for Pharmacological Research

Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum

The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be randomised to:

Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
617

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medizinische Universität Graz
      • Wien, Austria
        • Univ. Klinik Frauenheilkunde AKH
    • AT
      • Graz, AT, Austria, 8020
        • Krankenhaus Der Barmherzigen Brueder
      • Innsbruck, AT, Austria
        • Univ. Clinic for Gynaecology and Obstetrics - Medical University of Innsbruck
  • Belgium
      • Gent, Belgium
        • UZ Gent
      • Gent, Belgium
        • AZ Maria Middelares
    • BE
      • Bonheiden, BE, Belgium
        • Imeldaziekenhuis
      • Brasschaat, BE, Belgium
        • AZ Klina
      • Edegem, BE, Belgium
        • Antwerp University Hospital
      • Leuven, BE, Belgium
        • UZ Leuven
      • Namur, BE, Belgium
        • CMSE Clinique et Maternité Sainte-Elisabeth
      • Oostende, BE, Belgium
        • AZ Damiaan
      • Turnhout, BE, Belgium
        • Centrum Voor Oncologie
      • Verviers, BE, Belgium
        • Centre Hospitalier Peltzer La Tourelle (CHPLT)
      • Yvoir, BE, Belgium
        • CHU Dinant Godinne / UcL Namur
  • Denmark
    • DK
      • Odense, DK, Denmark
        • Odense University Hospital
  • Finland
      • Kuopio, Finland
        • Kuopio University Hospital - Kuopio
      • Oulu, Finland
        • Oulu University Hospital
    • FI
      • Tampere, FI, Finland, 33521
        • Tampere University Hospital
  • Germany
      • Brandenburg an der Havel, Germany
        • Staedtisches Klinikum Brandenburg
      • Dusseldorf, Germany
        • Universitätsfrauenklinik Düsseldorf
      • Essen, Germany
        • Kliniken Essen Mitte Evang. Huyssens Stiftung
      • Hamburg, Germany
        • University Medical Center Hamburg
      • Jena, Germany
        • Universitaetsklinikum Jena
      • Leverkusen, Germany
        • Klinikum Leverkusen gGmbH
      • Ravensburg, Germany
        • Studienzentrum Onkologie
      • Rostock, Germany
        • UFK am Klinikum Suedstadt Rostock
      • Speyer, Germany
        • Onkologische Schwerpunktpraxis
    • DE
      • Berlin, DE, Germany, 10117
        • Charite Universitaetsmedizin
      • Berlin, DE, Germany
        • Ev. Waldkrankenhaus Spandau
      • Berlin, DE, Germany
        • Praxis Dr. med. Jörg Schilling
      • Berlin, DE, Germany
        • Praxisklinik Krebsheilkunde für Frauen
      • Berlin, DE, Germany
        • Vivantes Netzwerk für Gesundheit GmbH
      • Dresden, DE, Germany
        • University Hospital Dresden
      • Fürstenwalde, DE, Germany
        • Dr. med. Georg Heinrich Schwerpunktpraxis für Gynäkologische Onkologie
      • Hamburg, DE, Germany
        • Kath. Marienkrankenhaus
      • Heidelberg, DE, Germany
        • Universitäts - Frauenklinik -Tübingen
      • Krefeld, DE, Germany
        • Helios Klinikum Krefeld
      • Lübeck, DE, Germany
        • "Universitätsklinikum Schleswig-Holstein
  • Italy
      • Catanzaro, Italy
        • AOU Materdomini
      • Napoli, Italy
        • Universita degli Studi di Napoli Federico II
      • Novara, Italy
        • Aou Maggiore Della Carita
      • Pagani, Italy
        • Presidio Ospedaliero A Tortora
      • Palermo, Italy
        • Casa di Cura La Maddalena
      • Palermo, Italy
        • ARNAS Civico
      • Taormina, Italy
        • Ospedale S. Vincenzo
      • Vercelli, Italy
        • ASL VC Ospedale S. Andrea - Vercelli
    • AL
      • Alessandria, AL, Italy
        • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
    • AO
      • Aosta, AO, Italy
        • Ospedale Regionale Umberto Parini
    • BI
      • Biella, BI, Italy
        • "Ospedale Degli Infermi - Biella"
    • BO
      • Bologna, BO, Italy
        • Policlinico S.Orsola Malpighi
    • BR
      • Brindisi, BR, Italy
        • P.O. "A.Perrino" ASL Brindisi
    • BS
      • Brescia, BS, Italy
        • A.O. Spedali Civili di Brescia
      • Brescia, BS, Italy
        • Fondazione Poliambulanza
    • CN
      • Cuneo, CN, Italy
        • Azienda Ospedaliera S. Croce e Carle
    • CO
      • Como, CO, Italy
        • Ospedale Valduce
    • CT
      • Catania, CT, Italy
        • Azienda Ospedaliero Universitaria "Policlinico- Vittorio Emanuele" P.O. Gaspare Rodolico
    • FC
      • Meldola, FC, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola e Cesena
    • FI
      • Empoli, FI, Italy
        • Ospedale San Giuseppe - Azienda USL11
    • FR
      • Sora, FR, Italy
        • Ospedale SS Trinità - Sora
    • GE
      • Genova, GE, Italy, 16128
        • Ente Ospedaliero Ospedali Galliera
      • Genova, GE, Italy
        • IRCCS San Martino IST - Genova
    • LC
      • Lecco, LC, Italy
        • AO della Provincia di Lecco - Ospedale Alessandro Manzoni
    • LE
      • Lecce, LE, Italy
        • Ospedale Vito Fazzi
    • MI
      • Milan, MI, Italy, 20141
        • European Institute of Oncology, Department of Surgery Science
    • MO
      • Modena, MO, Italy
        • Azienda Ospedaliero Universitaria Policlinico di Modena
    • PA
      • Palermo, PA, Italy
        • AO Ospedali Riuniti Villa Sofia Cervello
    • PC
      • Piacenza, PC, Italy
        • Ospedale Guglielmo da Saliceto - Piacenza
    • PD
      • Padova, PD, Italy, 35128
        • Istituto Oncologico Veneto
    • PI
      • Pisa, PI, Italy, 56126
        • Ospedale Santa Chiara
    • PO
      • Prato, PO, Italy
        • Nuovo Ospedale di Prato S. Stefano
    • PZ
      • Rionero in Vulture, PZ, Italy
        • Istituto di Ricovero e Cura a Carattere Scientifico - Centro Regionale Oncologico Basilicata
    • RA
      • Faenza, RA, Italy
        • Ospedale Di Faenza
      • Lugo, RA, Italy
        • Ospedale Umberto I
    • RC
      • Reggio Calabria, RC, Italy
        • Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
    • RE
      • Reggio Emilia, RE, Italy
        • IRCCS - Arcispedale S. Maria Nuova
    • RM
      • Roma, RM, Italy
        • Policlinico Umberto I, Universitàdi Roma "La Sapienza"
    • RN
      • Rimini, RN, Italy
        • Ospedale Infermi
    • SO
      • Sondrio, SO, Italy
        • Ospedale Civile Di Sondrio
    • TN
      • Trento, TN, Italy
        • Ospedale di Santa Chiara
    • TO
      • Candiolo, TO, Italy
        • Fondazione Piemontese Per L'Oncologia - IRCCS, Candiolo
      • Torino, TO, Italy, 10126
        • AOU Città della salute e della scienza - OIRM S. Anna
      • Torino, TO, Italy, 10128
        • Ospedale Mauriziano
      • Torino, TO, Italy
        • Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino - P.O. S. Anna
    • VA
      • Varese, VA, Italy
        • Ospedale Del Ponte - Varese
    • VE
      • Mirano, VE, Italy
        • U.L.S.S. 13 Mirano - Dolo - Noale
    • VR
      • Negrar, VR, Italy
        • Sacro Cuore Don Calabria
  • Netherlands
    • NL
      • Nijmegen, NL, Netherlands, 6525
        • Radboud University Medical Centre
  • Norway
      • Oslo, Norway
        • Radium Hospitalet Oslo University Hospital
      • Stavanger, Norway
        • Stavanger University Hospital
      • Tromsø, Norway
        • University Hospital of North Norway
  • Spain
      • Cordoba, Spain
        • Hospital Reina Sofía
      • El Palmar, Spain
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Terrassa, Spain
        • Consorci Sanitari de Terrassa
      • Valencia, Spain
        • Hospital Universitario Dr Peset
      • Valencia, Spain
        • Hospital Lluis Alcanyis Xativa
    • ES
      • Alicante, ES, Spain
        • Hospital General Universitario de Elche
      • Badalona, ES, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcellona, ES, Spain
        • Institut Català d´Oncologia, Hospitalet - Hospitalet de Llobregat
      • Castèllo, ES, Spain
        • Consorcio Hospitalario Provincial de Castellon
      • Girona, ES, Spain
        • Institut Catala d'Oncologia de Girona
      • Lleida, ES, Spain, 25598
        • H. U. Arnau de Vilanova
      • Madrid, ES, Spain
        • MD Anderson Cancer Center
      • Manresa, ES, Spain
        • Althaia
      • Murcia, ES, Spain
        • Hospital Universitario J.M. Morales Meseguer
      • Palma de Mallorca, ES, Spain
        • Hospital Son Espases
      • Palma de Mallorca, ES, Spain
        • Hospital Son Llatzer
      • Pamplona, ES, Spain
        • Complejo Hospitalario de Navarra
      • Sabadell, ES, Spain
        • Corporacion Sanitaria y Universitaria Parc Tauli
      • San Sebastian, ES, Spain
        • Hospital Universitario Donostia - San Sebastian
      • Valencia, ES, Spain
        • Hospital General Universitario de Valencia
      • Valencia, ES, Spain
        • Hospital La Fe
      • Valencia, ES, Spain
        • IVO Instituto Valenciano de Oncología
  • Switzerland
    • CH
      • Aarau, CH, Switzerland
        • Kantonsspital Aarau
      • Basel, CH, Switzerland
        • Frauenklinik -Universitätsspital Basel
      • Bern, CH, Switzerland
        • Klinik Engeried
      • Bern, CH, Switzerland
        • Universitätsklinik für Frauenheilkunde, Universitätsklinik für Onkologische Medizin - Inselspital
      • Chur, CH, Switzerland
        • Kantonsspital Graubünden
      • Frauenfeld, CH, Switzerland
        • Kantonsspital Frauenfeld
      • Luzern, CH, Switzerland
        • Luzerner Kantonsspital
      • Münsterlingen, CH, Switzerland
        • Kantonsspital Münsterlingen
      • Olten, CH, Switzerland
        • Kantonsspital Olten
      • St. Gallen, CH, Switzerland
        • Kantonsspital St. Gallen
      • Winterthur, CH, Switzerland
        • Kantonsspital
      • Zürich, CH, Switzerland
        • Frauenklinik - Stadtspital Triemli
    • TI
      • Bellinzona, TI, Switzerland
        • Ospedale Regionale Bellinzona e Valli - Istituto Oncologico Della Svizzera Italiana (IOSI)
  • United Kingdom
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Cardiff, United Kingdom
        • Velindre Cancer Center
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • Oxford, United Kingdom
        • The Churchill Hospital
      • Worthing, United Kingdom
        • Worthingh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female, aged ≥ 18 years
  2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
  3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane
  4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  6. Estimated life expectancy ≥ 12 weeks
  7. Patients must be accessible for treatment and follow-up
  8. Adequate organ function within 14 days prior to first cycle as evidenced
  9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
  10. Informed consent of the patient

Exclusion Criteria:

  1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
  2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
  3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
  4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
  5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  6. History of liver disease
  7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
  9. Prior exposure to trabectedin
  10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
  11. Prior severe PLD related toxicity
  12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
  13. Treatment with any investigational product within 30 days prior to inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Carboplatin plus PLD
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.
Drug: Carboplatin
Carboplatin AUC 5
Other Names:
  • Carboplatin generic
Drug: Pegylated Lipoxomal Doxorubicin (PLD)
PLD 30 mg/m² i.v.
Other Names:
  • Caelyx
Experimental: Trabectedin plus PLD
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.
Drug: Pegylated Lipoxomal Doxorubicin (PLD)
PLD 30 mg/m² i.v.
Other Names:
  • Caelyx
Drug: Trabectedin
trabectedin 1.1 mg/m2 3-hour i.v. infusion on Day 1 every 3 weeks. The use of central venous access is strongly recommended.
Other Names:
  • Yondelis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled
This is an event driven study. The study will continue until 442 events have occurred.
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Objective RR
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
CA-125 serological response
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
CA-125 serological response will be the best response obtained in each arm
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Duration of Response
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Duration of response: will be calculated from the date of first documentation of response (CR or partial response [PR], whichever occurs first) to the date of documented PD or death.
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Time to subsequent chemotherapy administration
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
OS for Subsequent chemotherapies
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
the overall survival counted from the administration of subsequent chemotherapy until death
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
PFS for the Subsequent Chemotherapies
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
the progression free survival counted from the administration of subsequent chemotherapy untill disease progression or death whichever occurs first
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Frequency of serious adverse events (SAEs)
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Number of SAEs for each randomization arm
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
QoL according to the EORTC QLQ-C30 and QLQ-OV28
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Best response to each Subsequent chemotherapy line
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
The best response obtained to each Subsequent chemotherapy line calculated as frequency of patients with CR, PR, SD or PD.
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Frequency of toxicities, graded according to the NCI-CTAE version 4.0
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Clinical and laboratory toxicities
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Frequency of toxicities leading to dose delays
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Clinical and laboratory toxicities
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Frequency of toxicities leading to dose modifications
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Clinical and laboratory toxicities
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Frequency of toxicities leading to treatment discontinuation
Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Clinical and laboratory toxicities
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mario Negri Institute for Pharmacological Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PharmaMar
Averion International Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicoletta Colombo, MD, European Institute of Oncology (I.E.O), Milan, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ET-D-009-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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