- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464201
Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GREKO III Study (GREKO III)
February 21, 2023 updated by: Grupo Español de Tumores Huérfanos e Infrecuentes
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".
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Barcelona, Spain
- Hospital de Mar
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Córdoba, Spain
- Hospital Reina Sofia
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Madrid, Spain
- Hospital Universitario La Paz
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Madrid, Spain
- Hospital Madrid Sanchinarro (CIOCC)
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Palma De Mallorca, Spain
- Hospital Son Llatzer
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Pamplona, Spain
- Hospital de Navarra
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Santiago De Compostela, Spain
- Complejo Hospitalario Universitario de Santiago
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Valencia, Spain
- Hospital La Fe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enzalutamide
Enzalutamide 160 mg daily p.o. (4 capsules 40mg per day)
|
Enzalutamide 160 mg p.o. every day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Up to 6 months
|
Number of responses according to RECIST 1.1 criteria
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical benefit rate
Time Frame: Up to 6 months
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Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria.
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Up to 6 months
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Progression-free survival (PFS)
Time Frame: Up to 6 months
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Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause
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Up to 6 months
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Overall survival (OS)
Time Frame: Up to 6 months
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Number of deaths for any cause.
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Up to 6 months
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Incidence of Treatment-Emergent Adverse Events
Time Frame: Up to 6 months
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Number of Adverse Events per patient
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Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2018
Primary Completion (Actual)
November 11, 2020
Study Completion (Actual)
November 11, 2020
Study Registration Dates
First Submitted
February 19, 2018
First Submitted That Met QC Criteria
March 12, 2018
First Posted (Actual)
March 13, 2018
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GETHI 2016-01
- 2015-004469-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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