Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GREKO III Study

Ovarian Cancer Clinical Trial

— GREKO III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464201
• Other study ID #: GETHI 2016-01
• Secondary ID: 2015-004469-10
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2018
• Est. completion date: November 11, 2020

Study information

• Verified date: February 2023
• Source: Grupo Español de Tumores Huérfanos e Infrecuentes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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). If this material is not available, principal investigator of the study will confirm eligibility of the patient.

• Metastatic or unresectable disease

• Radiologically measurable disease. In case you there is not measurable disease, principal investigator of the study will confirm eligibility of the patient. - - Life expectancy = 12 weeks

• Patients with adequate hepatic function, defined by: Aspartate transaminase (AST) and alanine aminotransferase (ALT) serum values = 3 x upper limit of normal (except in the presence of metastasis in which case values = 5 x upper limit of normal will be allowed), Total bilirubin values = 1,5 x upper limit of normal

• Patients with adequate bone marrow function, defined by: Absolute neutrophil count = 1.5 x 109 / L, Platelets =100 x 109/L, Hemoglobin = 9 g/dL

• Patients with adequate renal function: serum creatinine = 1,5 x upper limit of normal

• Absence of any disability to follow the study protocol

• Women childbearing potential who are sexually active, not undergoing hysterectomy or double adnexectomy, should follow the following contraceptive indications: Negative Pregnancy Test in serum or urine in the 72 hours before the start of treatment, use of a medically accepted method of contraception during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment.

Exclusion Criteria:

• Patients with another primary tumor 2 years before beginning the drug under study, with the exception of adequately treated or totally surgically removed cervical carcinoma in-situ or basalioma or superficial bladder carcinoma

• Patients who have received radical radiotherapy = 4 weeks prior to the start of study treatment or who have not recovered from toxicities of radiotherapy. Palliative radiation therapy for painful bone lesions bone is allowed up to 14 days prior to the beginning of the study treatment

• History of seizures or any conditions that may predispose to suffer them

• Current or previously treated brain metastases or disease leptomeningeal.

• Patients with cardiac insufficiency or heart disease clinically significant including any of the following: History or presence of uncontrolled severe ventricular arrhythmias, clinically significant resting bradycardia, any of the following diseases within 6 months prior to the start of the study drug -Myocardial infarction (MI), severe or unstable angina, coronary revascularization, congestive cardiac insufficiency (CCI), cerebrovascular accident (CVA), transient ischemic accident (TIA)-

• Patients with altered gastrointestinal function or with gastric disease that significantly alters the absorption of enzalutamide, such as for example: severe ulcer diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small bowel or inability to swallow oral medication. The previous partial or total gastrectomy is not an exclusion criterion.

• Diagnosis of human immunodeficiency virus (HIV) infection.

• Pregnant or lactating women.

• Women of childbearing potential not using an effective contraceptive method. - Patients who do not want or can follow the study protocol.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Enzalutamide 40 MG
Enzalutamide 160 mg p.o. every day

Locations

Country	Name	City	State
Spain	Hospital de Mar	Barcelona
Spain	Hospital Reina Sofia	Córdoba
Spain	Hospital Madrid Sanchinarro (CIOCC)	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Son Llatzer	Palma De Mallorca
Spain	Hospital de Navarra	Pamplona
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela
Spain	Hospital La Fe	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Español de Tumores Huérfanos e Infrecuentes	Apices Soluciones S.L., Astellas Pharma Inc

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Number of responses according to RECIST 1.1 criteria	Up to 6 months
Secondary	Clinical benefit rate	Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria.	Up to 6 months
Secondary	Progression-free survival (PFS)	Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause	Up to 6 months
Secondary	Overall survival (OS)	Number of deaths for any cause.	Up to 6 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Number of Adverse Events per patient	Up to 6 months