Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

30. juli 2026 oppdatert av: Verastem, Inc.

Open-Label Extension Study to Provide Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination with defactinib. The study is designed to support patients in France with access to avutometinib and defactinib who maintain ongoing clinical benefit while collecting safety and tolerability data during extended treatment. Participation is restricted to patients transferring directly from VS-6766-201(RAMP-201), ensuring continuity of care without enrollment of new patients.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

2

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Lyon, Frankrike, 69008
      • Paris, Frankrike, 75248
        • Institut Curie
        • Hovedetterforsker:
          • Manuel Rodrigues, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.

  4. Ability and willingness to provide written informed consent for participation in the study and for continued data collection.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study.
  4. Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study.
  5. 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.
  6. 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).
  7. 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).
  8. Positive pregnancy test at Screening, breastfeeding, or unwillingness to use adequate contraception during the study.
  9. Any condition or circumstance that, in the investigator's opinion, may compromise participant safety, compliance or continued benefit from study treatment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Andre navn:
  • avutometinib (VS-6766) og defactinib (VS-6063)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: MD Verastem, Verastem Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

3. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

30. juli 2026

Først lagt ut (Faktiske)

5. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere