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A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors - PM1183-B-005-14

Studio Clinico

Patologia: Neoplasie della mammella, Tumori dell’utero, Tumori della testa e del collo, Tumori neuroendocrini, Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Age ≥ 18 years.
- Voluntary signed informed consent (IC)
- Pathologically proven diagnosis of any of the following malignancies:
    - Small cell lung cancer (SCLC).
    - Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
    - Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
    - Biliary tract carcinoma.
    - Endometrial carcinoma.
    - BRCA 1/2- associated metastatic breast carcinoma
    - Carcinoma of unknown primary site.
    - Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
    - Ewing's family of tumors (EFTs)
- Prior treatment. Patients must have received:
    - SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
    - H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
    - GCTs: no limit of prior therapy
    - EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
    - BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
- Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
- Adequate major organ function
- At least three weeks since the last chemotherapy
- Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry

Criteri di esclusione: 

- Prior treatment with PM01183 or trabectedin
- Prior or concurrent malignant disease unless in complete remission for more than five years
- Known central nervous system (CNS) involvement
- Relevant diseases or clinical situations which may increase the patient's risk
- Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception

Trattamento sperimentale: 

Lurbinectedin (PM01183)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall response rate (ORR) [Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort)]
Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR)

Centri partecipanti

Nord Italia

IRCCS Istituto Ortopedico Rizzoli
Via di Barbiano 1/10 - 40136 Bologna - BO

Riferimento: Dr.ssa Alessandra Longhi
Telefono: 0516366411
Email: alessandra.longhi@ior.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Filippo De Marinis
Telefono: 0257489773
Email: filippo.demarinis@ieo.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282244080
Email: armando.santoro@cancercenter.humanitas.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Dr. Diego Cortinovis
Email: d.cortinovis@hsgerardo.org

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA

Riferimento: Dr. Manolo D'Arcangelo

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2014-003773-42

Data di inserimento: 31.10.2018

Promotore

PharmaMar

CRO

CHILTERN

Principal Investigator ITALIA

Istituto Clinico Humanitas - Rozzano

Riferimento: Prof. Armando Santoro

Telefono: 0282244080

Email: armando.santoro@cancercenter.humanitas.it

Localita: Rozzano (Mi)

 

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