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An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma - INCB59872-103

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, I B

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
- Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
- Must not be a candidate for potentially curative therapy or standard-of-care approved therapy.
- Measurable disease by computed tomography or magnetic resonance imaging based on RECIST 1.1 as determined by site radiology.
- Eastern Cooperative Oncology Group performance status 0 to 2.
- Willingness to avoid pregnancy or fathering children.

Criteri di esclusione: 

- Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
- Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
- Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
- Laboratory values outside the protocol-defined range at screening.
- History or evidence of bleeding disorder or active clinically significant bleeding requiring medical intervention.

Schema di trattamento: 

Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria.
Part 2: Expansion with the recommended dose from Part 1.

Trattamento sperimentale: 

INCB059872

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Number of adverse events [ Time Frame: Screening through 30 days after last dose of study treatment, up to approximately 6 months. ]
    Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related

Centri partecipanti

Nord Italia

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

Riferimento: Dr.ssa Stefania Salvagni
Email: stefania.salvagni@aosp.bo.it

 

Centro Italia

Ospedale Pediatrico Bambin Gesù
Piazza Sant Onofrio 4 - 00165 Roma - RM

Riferimento: Dr. Giuseppe Milano
Telefono: 0668592444
Email: giuseppemaria.milano@opbg.net

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03514407

Data di inserimento: 26.03.2019

Promotore

Incyte Corporation

CRO

/

Principal Investigator ITALIA

Ospedale pediatrico Bambino Gesù, Roma

Riferimento: Dr. Giuseppe Milano

Telefono: 0668592444

Email: giuseppemaria.milano@opbg.net

Localita: Roma

 

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