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Report for Clinical Trial NCT03464201

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label Phase II Clinical Trial of Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GreKo III Study

The good tolerability profile of enzalutamide, the fact that the administration of steroids is not necessary and the impressive results achieved in prostate cancer, make this drug an ideal candidate to be tested in ovarian granulosa cancer, a tumor that could somehow be considered as "female prostate cancer".

NCT03464201 Ovarian Cancer
MeSH:Ovarian Neoplasms
HPO:Ovarian neoplasm

1 Interventions

Name: Enzalutamide 40 MG

Description: Enzalutamide 160 mg p.o. every day
Type: Drug
Group Labels: 1

Enzalutamide


Primary Outcomes

Description: Number of responses according to RECIST 1.1 criteria

Measure: Overall response rate (ORR)

Time: Up to 6 months

Secondary Outcomes

Description: Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria.

Measure: Clinical benefit rate

Time: Up to 6 months

Description: Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause

Measure: Progression-free survival (PFS)

Time: Up to 6 months

Description: Number of deaths for any cause.

Measure: Overall survival (OS)

Time: Up to 6 months

Description: Number of Adverse Events per patient

Measure: Incidence of Treatment-Emergent Adverse Events

Time: Up to 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 C134W

Inclusion Criteria: - Patients who have given written informed consent - Women aged 18 years or over - Eastern Cooperative Oncology Group (ECOG) ≤ 1 - Diagnosis of histologically confirmed ovarian granulose carcinoma - Availability of sufficient biopsy material for confirmation of the diagnosis by a centralized pathologist and determination of the mutation FOXL2402C→ G(C134W). --- C134W ---



HPO Nodes


HPO: