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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

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

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:
Ovarian neoplasm
Genes 86
VAMP7 ZFPM2 CTNNB1 PTEN AKT1 WT1 FGFR2 AKT1 OPCML SOX9 BRCA2 BRCA1 PTEN MLH1 SUFU EWSR1 PMS2 IDH1 LMNA RAD51C RAD51C STAG3 GATA4 PALLD PIK3CA CHEK2 BRIP1 MRE11 FGFR2 TP53 RAD51D PRKN MSH6 EPCAM WT1 NR0B1 WT1 KRAS DICER1 TGFBR2 IDH2 SRY BRCA1 FAN1 DMRT3 MSH3 TP53 KRAS NR5A1 INHBA RNF43 KEAP1 DICER1 BARD1 SMAD4 RAD50 MSH2 NBN WNT10A C11ORF95 MLH3 PTCH2 CDH1 WRN PTEN PALB2 MAP3K1 PIK3CA RELA MAP3K1 PALB2 WT1 PMS2 BRCA2 PTEN BRCA1 RAD51 BRCA1 BRCA2 PTCH1 FLI1 PTEN PMS1 PTCH1 CDKN2A WWOX