Luspatercept in Metastatic AGCT of the Ovary

NCT06254781 | Completed

• 2 other identifiers: OZUHN-01522-5326
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult Granulosa Cell Tumor of the Ovary

Outcome Measures

Primary Outcomes (3)

• Objective response

  By computed tomography (CT) scans

  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

  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

  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..

Study Arms (1)

Luspatercept in metastatic AGCT of the ovary

EXPERIMENTAL

Luspatercept, 1.0 mg/kg, subcutaneously, every three weeks

Drug: Luspatercept

Interventions

Luspatercept DRUG

Erythroid Maturation Agent

Also known as: Reblozyl

Luspatercept in metastatic AGCT of the ovary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• N/A

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Granulosa cell tumor of the ovary

Interventions

luspatercept

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: February 12, 2024
• Study Start: May 30, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 29, 2022
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CA (1)