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A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors - Brigatinib-1001

Studio Clinico

Patologia: Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria:
    - With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.
    - With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.
    - With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or
    - With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.
2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.
4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.
5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).

Criteri di esclusione: 

1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.
2. Prior therapy with brigatinib.
3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.
4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.
5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.
7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.

Schema di trattamento: 

 

Trattamento sperimentale: 

Midazolam 3 mg + Brigatinib 90 mg

Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1.
After completion of Part A, participants will continue into Part B.
Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
U.O. Oncologia Medica

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Dr. Luca Gianni
Telefono: 0226436529
Email: fugazza.clara@hsr.it

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
U.O. Oncologia Medica - NB: Il centro non è ancora aperto all'arruolamento dei pazienti

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
SOC Oncologia Medica e dei Tumori Immunocorrelati

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Dipartimento di Oncologia-Ematologia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-001624-19

Data di inserimento: 25.07.2019

Promotore

Ariad Pharmaceuticals

CRO

NA

Principal Investigator ITALIA

Ospedale San Raffaele IRCCS, Milano

Riferimento: Dr. Luca Gianni

Telefono: 0226436529

Email: fugazza.clara@hsr.it

Localita: Milano

 

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