- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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)
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Verastem Call Center
- Telefonnummer: 781-292-4204
- E-Mail: clinicaltrials@verastem.com
Studienorte
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Lyon, Frankreich, 69008
- Centre Léon Bérard
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Hauptermittler:
- Isabelle Ray-Coquard, MD
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Kontakt:
- Isabelle Ray-Coquard, MD
- Telefonnummer: +33 478782888/5912
- E-Mail: isabelle.ray-coquard@lyon.unicancer.fr
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Paris, Frankreich, 75248
- Institut Curie
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Hauptermittler:
- Manuel Rodrigues, MD
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Kontakt:
- Manuel Rodrigues, MD
- E-Mail: manuel.rodrigues@curie.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
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Avutometinib: administered orally twice a week Defactinib: administered orally twice daily
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Zeitfenster: Until treatment discontinuation (approximately 20 months)
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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).
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Until treatment discontinuation (approximately 20 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Zeitfenster: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
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Treatment-emergent adverse events will be collected and summarized for participants receiving extended treatment with avutometinib alone or in combination with defactinib.
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From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: MD Verastem, Verastem Oncology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Erkrankungen des endokrinen Systems
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Genitalerkrankungen, weiblich
- Neoplasmen der endokrinen Drüse
- Eierstockerkrankungen
- Adnexerkrankungen
- Genitale Neubildungen, weiblich
- Gonadenstörungen
- Eierstocktumoren
- Defactinib
Andere Studien-ID-Nummern
- VS-6766-206
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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