CompletedNot Applicable

Luspatercept in Metastatic AGCT of the Ovary

Canada1 participantsStarted 2022-05-30

Plain-language summary

This is a single participant study of luspatercept for the treatment of a patient with dult granulosa cell tumor (AGCT) of the ovary.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * N/A Exclusion Criteria: * N/A This patient's case was recently discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and gynecologic medical oncology departments. The discussion surrounded the best next therapeutic option in this rare cancer subtype without clear standard of care guidelines. The recommendation from this discussion was to investigate targets of the TGFβ pathway, such as luspatercept. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.

What they're measuring

Objective response

Timeframe: From baseline CT until disease progression or until the investigator deems that it is in the patient's best interest to stop study treatment, whichever came first, assessed up to 3 months.

Eastern Cooperative Oncology Group (ECOG) score

Timeframe: From baseline ECOG until disease progression or until the investigator deems that it is in the patient's best interest to stop study treatment, whichever came first, assessed up to 3 months.

Circulating tumor DNA (ctDNA) levels

Timeframe: From baseline ctDNA until disease progression or until the investigator deems that it is in the patient's best interest to stop study treatment whichever came first, assessed up to 3 months..

Trial details

NCT IDNCT06254781

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-22

View on ClinicalTrials.gov More Adult Granulosa Cell Tumor of the Ovary trials