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Trial record 1 of 1 for:    gethi 2016-01
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Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GREKO III Study (GREKO III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03464201
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Astellas Pharma Inc
Apices Soluciones S.L.
Information provided by (Responsible Party):
Grupo Español de Tumores Huérfanos e Infrecuentes

Brief 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".

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Enzalutamide 40 MG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase II Clinical Trial of Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GreKo III Study
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Enzalutamide
Enzalutamide 160 mg daily p.o. (4 capsules 40mg per day)
Drug: Enzalutamide 40 MG
Enzalutamide 160 mg p.o. every day




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to 6 months ]
    Number of responses according to RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Clinical benefit rate [ Time Frame: Up to 6 months ]
    Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria.

  2. Progression-free survival (PFS) [ Time Frame: Up to 6 months ]
    Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause

  3. Overall survival (OS) [ Time Frame: Up to 6 months ]
    Number of deaths for any cause.

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 6 months ]
    Number of Adverse Events per patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Due to kind of disease only female patients are acceptable for the trial
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464201


Contacts
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Contact: Garcia-Donas 0034917567984 jgarciadonas@gmail.com

Locations
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Spain
Hospital de Mar Recruiting
Barcelona, Spain
Hospital Reina Sofia Recruiting
Córdoba, Spain
Hospital Madrid Sanchinarro (CIOCC) Recruiting
Madrid, Spain
Contact: Garcia-Donas, MD    +34 91 756 79 84    jgarciadonas@gmail.com <jgarciadonas@gmail.com>   
Hospital Universitario La Paz Recruiting
Madrid, Spain
Hospital Son Llatzer Recruiting
Palma De Mallorca, Spain
Hospital de Navarra Recruiting
Pamplona, Spain
Complejo Hospitalario Universitario de Santiago Recruiting
Santiago De Compostela, Spain
Hospital La Fe Recruiting
Valencia, Spain
Sponsors and Collaborators
Grupo Español de Tumores Huérfanos e Infrecuentes
Astellas Pharma Inc
Apices Soluciones S.L.
Investigators
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Principal Investigator: Garcia-Donas, MD CIOCC (Hospital Universitario HM Sanchinarro)
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Responsible Party: Grupo Español de Tumores Huérfanos e Infrecuentes
ClinicalTrials.gov Identifier: NCT03464201    
Other Study ID Numbers: GETHI 2016-01
2015-004469-10 ( EudraCT Number )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders