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Luspatercept in Metastatic AGCT of the Ovary

NCT06254781CompletedNAINTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

University Health Network, Toronto

Enrollment

Start Date

2022-05-30

Completion Date

2022-08-22

Study Type

INTERVENTIONAL

Official Title

Luspatercept in Metastatic Adult Granulosa Cell Tumor (AGCT) of the Ovary

Interventions

Luspatercept

Conditions

Adult Granulosa Cell Tumor of the Ovary

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Objective response

By computed tomography (CT) scans

Time frame: 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

0\. Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Death

Time frame: 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

Observe change between baseline ctDNA until disease progression

Time frame: 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..

Locations

Princess Margaret Cancer Centre, Toronto, Canada