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I8X-MC-JECA: A Phase 1 Study of LY3200882 in Patients With Solid Tumors

Studio Clinico

Patologia: Tumori della testa e del collo, Epatocarcinoma, Carcinoma del pancreas esocrino, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- ≥ 18 years
- The participant must have histological or cytological evidence of cancer.
- Have adequate organ function.
- Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
- Are able to swallow capsules and tablets.

Criteri di esclusione: 

- Have moderate or severe cardiovascular disease.
- Have a serious concomitant systemic disorder.
- Have acute leukemia.

Trattamento sperimentale: 

LY3200882

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [Time Frame: Cycle 1 (28 days)]
2. Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)]

Obiettivi secondari dello studio: 

1. Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 [Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)]
2. PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 [Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)]
3. ORR: Percentage of Participants with CR or PR [Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)]
4. Overall Survival (OS) [Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months)]
5. Duration of Response (DoR) [Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months]
6. Progression-Free Survival (PFS) [Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months)]

Centri partecipanti

Nord Italia

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

Riferimento: Dr. Matteo Simonelli
Telefono: 0282244559
Email: matteo.simonelli@hunimed.eu

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

Riferimento: Dr. Davide Melisi
Telefono: 0458128148
Email: davide.melisi@univr.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-001431-12

Data di inserimento: 06.03.2019

Promotore

Eli Lilly and Company

CRO

/

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano (Mi)

Riferimento: Dr. Matteo Simonelli

Telefono: 0282244559

Email: matteo.simonelli@hunimed.eu

Localita: Rozzano (Mi)

 

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