- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07747506
Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Open-Label Extension Study to Provide Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Verastem Call Center
- Numero di telefono: 781-292-4204
- Email: clinicaltrials@verastem.com
Luoghi di studio
-
-
-
Lyon, Francia, 69008
- Centre Léon Bérard
-
Investigatore principale:
- Isabelle Ray-Coquard, MD
-
Contatto:
- Isabelle Ray-Coquard, MD
- Numero di telefono: +33 478782888/5912
- Email: isabelle.ray-coquard@lyon.unicancer.fr
-
Paris, Francia, 75248
- Institut Curie
-
Investigatore principale:
- Manuel Rodrigues, MD
-
Contatto:
- Manuel Rodrigues, MD
- Email: manuel.rodrigues@curie.fr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Currently active on VS-6766-201(RAMP-201) study while receiving avutometinib in combination with defactinib, have not required prior permanent discontinuation of avutometinib plus defactinib. Any active dose hold from the RAMP-201 study should be ≤ 28 days at the time of Screening for the OLE study.
- Investigator assessment that the participant is deriving clinical benefit from study treatment (e.g., complete response, partial response, or stable disease), as determined by the investigator.
Female participants of childbearing potential must agree to use a highly effective method of contraception throughout OLE study participation and for at least 30 days after the last dose of study treatment.
Note: Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening/Eligibility prior to the first OLE dose.
- Ability and willingness to provide written informed consent for participation in the study and for continued data collection.
Exclusion Criteria:
- Radiographic or clinical disease progression or discontinuation of treatment for any reason during the VS-6766-201 (RAMP-201) study or at the time of screening in this study.
- Participants on an active dose hold in the VS-6766-201 (RAMP-201) study may transition to this study only after the underlying issue has been clinically resolved and the investigator, in consultation with the Sponsor, confirms that continued treatment is appropriate.
- Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study.
- Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study.
- Any active or uncontrolled medical condition that, in the investigator's judgment, would pose unacceptable risk or interfere with continued treatment, including but not limited to severe cardiac, pulmonary, neurologic, dermatologic, gastrointestinal, hepatic, or active infectious disease.
- Any active or history of clinically significant ocular disorder that may increase the risk of MEK-inhibitor-related ocular toxicity (e.g., retinal vein occlusion, serous retinopathy, retinal detachment, or clinically significant macular pathology).
- Concomitant use of medications known to have clinically significant interactions with avutometinib or defactinib that cannot be safely discontinued or substituted prior to study dosing (e.g., strong CYP3A4 inducers or inhibitors, warfarin).
- Positive pregnancy test at Screening, breastfeeding, or unwillingness to use adequate contraception during the study.
- Any condition or circumstance that, in the investigator's opinion, may compromise participant safety, compliance or continued benefit from study treatment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Continued Treatment of Avutometinib + Defactinib
To provide continued treatment with avutometinib in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the VS-6766-201 (RAMP-201) study
|
Avutometinib: administered orally twice a week Defactinib: administered orally twice daily
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Lasso di tempo: Until treatment discontinuation (approximately 20 months)
|
Treatment exposure will be summarized descriptively for participants receiving continued treatment with avutometinib in combination with defactinib after completion of Study VS-6766-201 (RAMP-201).
|
Until treatment discontinuation (approximately 20 months)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Lasso di tempo: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
|
Treatment-emergent adverse events will be collected and summarized for participants receiving extended treatment with avutometinib alone or in combination with defactinib.
|
From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: MD Verastem, Verastem Oncology
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Neoplasie delle ghiandole endocrine
- Malattie ovariche
- Malattie annessiali
- Neoplasie genitali, femmina
- Disturbi gonadici
- Neoplasie ovariche
- defactinib
Altri numeri di identificazione dello studio
- VS-6766-206
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .