Overcoming Endocrine Resistance in Metastatic Breast Cancer (OVER)

June 14, 2016 updated by: Consorzio Oncotech

A Randomized Trial With Factorial Design Comparing Fulvestrant ± Lapatinib ± Aromatase Inhibitor in Metastatic Breast Cancer Progressing After Aromatase Inhibitor Therapy

Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In presence of ER hypersensitivity even a small amount of ER may be sufficient for sustained growth signalling. On the other hand, ER disruption operated by fulvestrant is not complete, particularly in the initial phase of treatment. From phase III trials, indeed, The invertigators know that with the standard 250mg monthly dose the steady state of circulating drug is reached only after 5-6 injections. This may play a role since, as long as ER downregulation is concerned, a clear dose-response relationship has been reported. In such a situation, fulvestrant efficacy may be partial, particularly because the concomitant AI discharge yields a restoration of physiologic postmenopausal levels of circulating oestrogens. New dosing schedule are currently under investigation both to accelerate the achievement of the steady state (loading dose) and to achieve higher circulating drug levels (high dose) (86).

In this trial the investigators will be using the so-called 'loading dose'.

Further potential strategies to improve fulvestrant efficacy in this setting are:

A) avoid the restoration of circulating oestrogens; B) interfere with molecular mechanisms that produce ER hypersensitivity by targeting the EGFR/ERBB2/ERB3 system.

A) avoid the restoration of circulating oestrogens: this should be achieved by holding the AI treatment. Because some cases of progression upon AIs may be related to an inefficient inhibition of the aromatase it is a logical step to test whether changing AI class (from type I, steroidal, to type II, non steroidal, and vice-versa) (87), may improve fulvestrant efficay. In this view, pts in this trial will be randomized to receive fulvestrant (loading dose) with or without the alternate class AI treatment. Circulating oestrogens levels will be tracked to verify inhibition of aromatase for pts assigned to concurrent AI treatment.

B) Interfere with growth factors-mediated ER hypersensitivity: although fulvestrant is able to overcome the ER hypersensitivity of LTED (88) and produce a growth arrest, this activity may not be complete because of incomplete ER disruption, but also because of a direct stimulation of growth by the hyperactivated EGFR/ERBB2/ERB3 system. Laboratory evidence support this hypothesis. Indeed, breast cancer cell lines exposed to long-term treatment with fulvestrant became insensitive to the drug and restore growth (89). This growth does not appear, however, related to the development of direct resistance to the drug, since ER mediated signalling continue to be efficiently suppressed in these cells; rather it may be driven by the use of alternative growth-stimulating pathway, including the EGFR system. Indeed, it can be abrogated by the EGFR-tyrosine Kinase inhibitor Gefitinib (IRESSA™) and by an MAPK-inhibitor (90). Lapatinib (GW572016) is an orally active small molecule that reversibly inhibits ErbB1 and ErbB2 tyrosine kinases, which in turn blocks phosphorylation and activation of Erk1/2 (p-Erk1/2) and Akt (p-Akt) in ErbB1- and/ or ErbB2-expressing tumor cell lines and xenografts (91-94). Lapatinib elicits cytostatic or cytotoxic antitumor effects depending on the cell type (95;96). Because ErbB2-containing heterodimers exert potent mitogenic signals, simultaneously interrupting both ErbB1 and ErbB2 signaling is an appealing therapeutic approach. Moreover, ErbB3 signaling is also involved in lapatinib action. Indeed ErbB3 is kinase-dead and relies on ErbB2 for transactivation: ErbB2-ErbB3 heterodimers are potent activators of the PI3K-Akt survival pathway (97;98), which can, in turn, inhibited by lapatinib.

Based on its molecular mechanism of action, on its fair toxicity profile and on its promising, although preliminary, activity data, Lapatinib appears an ideal candidate to combine with Fulvestrant in the attempt to improve its efficacy in patients progressing on AIs.

Study Type

Interventional

Enrollment (Anticipated)

396

Phase

  • 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 Contact

  • Name: Clinical Research Technology
  • Phone Number: 0039089301545

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico U.O. Oncologia Medica e Sperimentale
        • Principal Investigator:
          • GIUSEPPE COLUCCI, Md
      • Benevento, Italy, 82100
        • Recruiting
        • Azienda Ospedaliera G. Rummo U.O. di Oncologia Medica
        • Principal Investigator:
          • Bruno Daniele, MD
      • Benevento, Italy, 82100
        • Recruiting
        • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' U.O. Oncologia
      • Brindisi, Italy, 72100
        • Recruiting
        • Presidio Ospedaliero 'Antonio Perrino' U.O.C. di Oncologia
      • Campobasso, Italy, 86100
        • Recruiting
        • dazione di Ricerca e Cura 'Giovanni Paolo II' U.O. di Ginecologia Oncologia
        • Principal Investigator:
          • GABRIELLA MARIA FERRANDINA, Md
      • Campobasso, Italy, 86100
        • Recruiting
        • Ospedale Civile di Campobasso - A. Cardarelli U.O.C. Oncologia Medica
        • Principal Investigator:
          • FRANCESCO CARROZZA, Md
      • Caserta, Italy, 81100
        • Recruiting
        • Azienda Ospedaliera 'Sant'Anna e San Sebastiano' U.O.C. di Oncologia
        • Principal Investigator:
          • LUIGI DE LUCIA, Md
      • Catania, Italy, 95122
        • Recruiting
        • Presidio Ospedaliero Garibaldi - Nesima S.C. di Oncologia Medica
        • Principal Investigator:
          • ROBERTO BORDONARO, Md
      • Catania, Italy, 95124
        • Recruiting
        • A.O.U. Ospedale Vittorio Emanuele e Ferrarotto U.O. di Oncologia Medica
        • Principal Investigator:
          • CALOGERO BUSCARINO, Md
      • Catania, Italy, 95126
        • Recruiting
        • Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
        • Principal Investigator:
          • MICHELE CARUSO, Md
      • Como, Italy, 22100
        • Recruiting
        • Azienda Ospedaliera S. Anna U.O. di Oncologia Medica
        • Principal Investigator:
          • Monica Giordano, MD
      • Ferrara, Italy, 44121
        • Recruiting
        • Arcispedaliera S. Anna di Ferrara U.O. Oncologia Clinica
        • Principal Investigator:
          • MONICA INDELLI, Md
      • Genova, Italy, 16132
        • Recruiting
        • I.R.C.C.S. A.O.U. San Martino - I.S.T. S.C. Oncologia Medica A
      • Isernia, Italy, 86170
        • Recruiting
        • ASRM - Ospedale F. Veneziale - Zona di Isernia U.O. Oncologia
        • Principal Investigator:
          • LIBERATO DI LULLO, Md
      • Latina, Italy, 04100
        • Recruiting
        • A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia Medica
        • Principal Investigator:
          • ENZO VELTRI, Md
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi U.O. di Oncologia
        • Principal Investigator:
          • ROSACHIARA FORCIGNANÒ, Md
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia (IRCCS) Dipartimento di Medicina - Unità Cure Mediche
        • Principal Investigator:
          • Franco Nolè, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Cardarelli Divisione Di Oncologia
        • Principal Investigator:
          • GIACOMO CARTENÌ, Md
      • Napoli, Italy, 80131
        • Recruiting
        • Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
      • Novara, Italy, 28100
        • Recruiting
        • A.O.U. 'Maggiore della Carità' S.C. Oncologia
        • Principal Investigator:
          • Oscar Alabisio, MD
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto - I.R.C.C.S. U.O. di Oncologia Medica II
        • Principal Investigator:
          • ANTONIO JIRILLO, Md
      • Palermo, Italy, 90127
        • Recruiting
        • A.O.U.P. 'Paolo Giaccone' U.O.C. di Oncologia Medica
        • Principal Investigator:
          • Antonio Russo, MD
      • Palermo, Italy, 90127
        • Recruiting
        • A.R.N.A.S - Ospedale Civico e Benfratelli G. Di Cristina e M. Ascoli Divisione di Oncologia Medica
        • Principal Investigator:
          • VITA LEONARDI, Md
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
      • Pavia, Italy, 27100
        • Active, not recruiting
        • IRCCS Policlinico S. Matteo S.C. di Oncologia Medica
      • Perugia, Italy, 06122
        • Recruiting
        • Ospedale S. Maria della Misericordia S.C. Oncologia Medica
        • Principal Investigator:
          • CARLO BASURTO, Md
      • Piacenza, Italy, 29121
        • Recruiting
        • AUSL di Piacenza - Ospedale U.O. Oncologia Medica
      • Pordenone, Italy, 33170
        • Recruiting
        • Azienda Ospedaliera Santa Maria degli Angeli U.O. Oncolgia Medica
        • Principal Investigator:
          • SILVANA SARACCHINI, Md
      • Reggio Calabria, Italy, 89125
        • Recruiting
        • Azienda Ospedaliera Bianchi - Melacrino - Morelli U.O. di Oncologia Medica
        • Principal Investigator:
          • MARIO NARDI, Md
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale S.Maria Nuova Servizio di Oncologia
      • Roma, Italy, 00144
        • Recruiting
        • Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica A
        • Principal Investigator:
          • FRANCESCO COGNETTI, mD
      • Roma, Italy, 00149
        • Recruiting
        • Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia Mammella
        • Principal Investigator:
          • ANNA MARIA PARISI, Md
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Universitario 'Agostino Gemelli' U.O.C. Ginecologia Oncologica
        • Principal Investigator:
          • Giovanni Scambia, MD
      • Roma, Italy, 00186
        • Recruiting
        • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina U.O. Oncologia
        • Principal Investigator:
          • ANGELO FEDELE SCINTO, Md
      • Roma, Italy, 00189
        • Recruiting
        • Azienda Ospedaliera S. Andrea - Università La Sapienza U.O.C. Oncologia
      • Roma, Italy, 00189
        • Recruiting
        • Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital Oncologico
        • Principal Investigator:
          • IDA PAVESE, Md
      • Salerno, Italy, 84126
        • Recruiting
        • Ospedale G. Da Procida - ASL SA U.O. di Oncologia
        • Principal Investigator:
          • MARIA LUISA BARZELLONI, Md
      • Salerno, Italy, 84131
        • Recruiting
        • Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
        • Principal Investigator:
          • CLEMENTINA SAVASTANO, Md
      • Sassari, Italy, 07100
        • Recruiting
        • Azienda Ospedaliera n. 1 - Annunziata Oncologia Medica
      • Sassari, Italy, 07100
        • Recruiting
        • Università di Sassari U.O. di Oncologia Medica
        • Principal Investigator:
          • MARIA GIUSEPPA SAROBBA, Md
      • Sondrio, Italy, 23100
        • Recruiting
        • Ospedale Civile di Sondrio - Azienda Ospedaliera Valtellina e Valchiavenna S.C. Oncologia Medica
        • Principal Investigator:
          • Alessandro Bertolini, MD
      • Torino, Italy, 10125
        • Recruiting
        • Ospedale Evangelico Valdese - ASL TO1 U.O. di Oncologia Medica
        • Principal Investigator:
          • ANNA TURLETTI, Md
      • Torino, Italy, 10126
        • Recruiting
        • Presidio San Lazzaro - A.O.U. San Giovanni Battista di Torino (Molinette) S.C. Oncologia Medica II
        • Principal Investigator:
          • Mario Airoldi, MD
      • Torino, Italy, 10126
        • Recruiting
        • Università degli Studi di Torino - Ospedale S. Anna U.O. di Oncologia Medica
        • Principal Investigator:
          • ANTONIO DURANDO, Md
      • Torino, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano Umberto I S.C.D.U. Ginecologia e Ostetricia
        • Principal Investigator:
          • NICOLETTA BIGLIA, Md
      • Trieste, Italy, 34147
        • Active, not recruiting
        • Centro Oncologico A.S.S. N°1 Triestina Centro Sociale Oncologico
      • Udine, Italy, 33100
        • Recruiting
        • A.O.U. ´S. Maria della Misericordia´ Dipartimento di Oncologia
      • Varese, Italy, 21100
        • Recruiting
        • Azienda Ospedaliera Circolo e Fondazione Macchi U.O. di Oncologia Medica
      • Viterbo, Italy, 01100
        • Recruiting
        • Presidio Ospedaliero 'Belcolle' U.O.C. Oncologia Medica
        • Principal Investigator:
          • LUCA MOSCETTI, Md
    • Ancona
      • Fabriano, Ancona, Italy, 60044
        • Recruiting
        • A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia Medica
        • Principal Investigator:
          • Rosa Rita Silva, MD
    • Bergamo
      • Treviglio, Bergamo, Italy, 24047
        • Recruiting
        • Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia Medica
        • Principal Investigator:
          • Sandro Barni, MD
    • Chieti
      • Lanciano, Chieti, Italy, 66034
        • Recruiting
        • Ospedale Civile Renzetti U.O. Oncologia Medica
        • Principal Investigator:
          • ANTONIO NUZZO, Md
    • Cosenza
      • Paola, Cosenza, Italy, 87027
        • Active, not recruiting
        • Ospedale S. Francesco da Paola U.O. Oncologia Medica
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Recruiting
        • IRCCS - 'Casa Sollievo della Sofferenza' U.O. Oncologia Medica
        • Principal Investigator:
          • EVARISTO MAIELLO, Md
    • Frosinone
      • Sora, Frosinone, Italy, 03039
        • Recruiting
        • Ospedale 'SS. Trinità' U.O. Oncologia Medica
    • Lucca
      • Lido Di Camaiore, Lucca, Italy, 55041
        • Recruiting
        • Ospedale Unico Versilia U.O. Oncologia Medica
    • Messina
      • Taormina, Messina, Italy, 98039
        • Recruiting
        • Ospedale Civico San Vincenzo U.O. Oncologia Medica
        • Principal Investigator:
          • FRANCESCO FERRAÙ, Md
    • Pisa
      • Pontedera, Pisa, Italy, 56025
        • Recruiting
        • Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia Medica
        • Principal Investigator:
          • Giacomo Allegrini, MD
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico S.O.C. di Oncologia Medica C
        • Principal Investigator:
          • SIMON SPAZZAPAN, Md
    • Potenza
      • Rionero in vulture, Potenza, Italy, 85028
        • Recruiting
        • Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica
        • Principal Investigator:
          • Michele Aieta, MD
    • Reggio Emilia
      • Correggio, Reggio Emilia, Italy, 42015
        • Recruiting
        • Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina Acuti
        • Principal Investigator:
          • ALESSANDRA ZOBOLI, Md
    • Salerno
      • Nocera Inferiore, Salerno, Italy, 84014
        • Recruiting
        • Azienda Ospedaliera - Ospedale Umberto I U.O. di Medicina e Oncoematologia
      • Vallo Della Lucania, Salerno, Italy, 84078
        • Recruiting
        • Presidio Ospedaliero di Vallo della Lucania U.O. Oncologia Medica
        • Principal Investigator:
          • PIETRO MASULLO, Md
    • Sondrio
      • Sondalo, Sondrio, Italy, 23035
        • Recruiting
        • AOVV - Ospedale E. Morelli S.O.C. Medicina Interna - D.H. Oncologico-Ematologico-Internistico
        • Principal Investigator:
          • Giuseppe Valmadre, MD
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.) Direzione di Oncologia Medica
        • Principal Investigator:
          • Massimo Aglietta, MD
        • Contact:
          • Massimo Aglietta, MD
    • Varese
      • Gallarate, Varese, Italy, 21013
        • Active, not recruiting
        • Ospedale 'S. Antonio Abate' U.O. Oncologia
      • Saronno, Varese, Italy, 21047
        • Recruiting
        • Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero Saronno S.C. Oncologia Medica
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • Ospedale Sacro Cuore - Don Calabria U.O.C. Oncologia Medica

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Provision of written informed consent
  2. Histological/cytological confirmation of breast cancer
  3. Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
  4. Postmenopausal women
  5. Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
  6. Patients demonstrating prior response to AI therapy
  7. Patients with measurable disease as per RECIST criteria /Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria.
  8. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
  9. Life expectancy of at least 8 months
  10. WHO performance status 0, 1 or 2
  11. Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
  12. Are able to swallow and retain oral medication;
  13. Are able to complete all screening assessments as outlined in the protocol;
  14. Patients must have normal organ and marrow function
  15. Left ventricular ejection fraction (LVEF) within the institutional normal range

Exclusion Criteria:

  1. Previous therapy with Fulvestrant and/or Lapatinib;
  2. Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
  3. Concurrent non study anti-cancer therapy (
  4. Have unresolved or unstable, serious toxicity from prior administration
  5. Have malabsorption syndrome,
  6. Have a concurrent disease or condition that would make the patient inappropriate for study participation,
  7. Have an active or uncontrolled infection;
  8. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  9. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
  10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
  11. Receive concurrent treatment with prohibited medications
  12. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
  13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM 1
Fulvestrant + Placebo Lapatinib
Drug: Fulvestrant
Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
Other Names:
  • Faslodex
Drug: Placebo Lapatinib
1500mg (TBD) O.S. qd
Other Names:
  • Placebo
Experimental: ARM 2
Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib
Drug: Fulvestrant
Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
Other Names:
  • Faslodex
Drug: Placebo Lapatinib
1500mg (TBD) O.S. qd
Other Names:
  • Placebo
Drug: Aromatase Inhibitors
as indicated in the Summary Product Characteristic
Other Names:
  • Aromatase Inhibitor
Experimental: ARM 3
Fulvestrant + Lapatinib
Drug: Fulvestrant
Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
Other Names:
  • Faslodex
Drug: Lapatinib
1500mg (TBD) O.S. qd
Experimental: ARM 4
Fulvestrant + Lapatinib + Aromatase Inhibitors
Drug: Fulvestrant
Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
Other Names:
  • Faslodex
Drug: Aromatase Inhibitors
as indicated in the Summary Product Characteristic
Other Names:
  • Aromatase Inhibitor
Drug: Lapatinib
1500mg (TBD) O.S. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Progression free survival (PFS): it is defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Progression
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Time to Progression (TTP): it is defined as the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Overall Survival
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Overall survival. (OS): it is defined as the time between the first study dose administration and the date death from any cause.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Response Rate:
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Response Rate: It will be classified according to the RECIST criteria.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Clinical Benefit Rate
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 6 months
Clinical Benefit Rate: it is defined as the sum of rates of PR, CR and SD lasting ≥ 6 months.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 6 months
Safety as measured by expected and Non-expected toxicity events
Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
To evaluate expected and Non-expected toxicity events that occur in more than 5% of patients in any of the study group, as reported by the CTC.
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Safety assessed by number of Participants with Adverse Events
Time Frame: time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Withdrawals from the treatment plan (causes of withdrawals will be compared per each study group).
time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

Collaborators and Investigators

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

Sponsor

Consorzio Oncotech

Investigators

  • Principal Investigator: Sabino De Placido, MD, Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
  • Study Chair: Michelino De Laurentiis, MD, Istituto Nazionale dei Tumori - Fondazione G. Pascale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

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Other Study ID Numbers

  • GIM8-OVER
  • 2007-006031-30 (EudraCT Number)

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