Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma (1403-0008)

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II, III

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF).
- Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS).
- Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
- Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available.
- Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review. 
- Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
- ECOG performance status 0-1. Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt.
- Adequate organ function.

Criteri di esclusione: 

- Known mutation in the TP53 gene (screening for TP53 status is not required).
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
- Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
- Previous or concomitant malignancies other than DDLPS or well differentiated liposarcoma (WDLPS), treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, and prostate cancer.
- Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).

Trattamento sperimentale: 

BI 907828

Trattamento di controllo: 

doxorubicina

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-002392-20

Data di inserimento: 21.07.2022

Data di aggiornamento: 27.03.2023

Promotore

Boehringer Ingelheim

CRO

IQVIA

Principal Investigator ITALIA

Policlinico Universitario Campus Biomedico, Roma

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Roma