NCT03464201

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

February 19, 2018

Last Update Submit

February 21, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    Number of responses according to RECIST 1.1 criteria

    Up to 6 months

Secondary Outcomes (4)

  • Clinical benefit rate

    Up to 6 months

  • Progression-free survival (PFS)

    Up to 6 months

  • Overall survival (OS)

    Up to 6 months

  • Incidence of Treatment-Emergent Adverse Events

    Up to 6 months

Study Arms (1)

Enzalutamide

EXPERIMENTAL

Enzalutamide 160 mg daily p.o. (4 capsules 40mg per day)

Drug: Enzalutamide 40 MG

Interventions

Enzalutamide 40 MGDRUG

Enzalutamide 160 mg p.o. every day

Enzalutamide

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue to kind of disease only female patients are acceptable for the trial
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)-
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital de Mar

Barcelona, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

Hospital Madrid Sanchinarro (CIOCC)

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Related Publications (1)

  • Garcia-Donas J, Redondo A, Santaballa A, Garrigos L, Rubio MJ, Lainez N, Gonzalez MI, Cueva JF, Barquin A, Grazioso TP, Hurtado A, Sevillano E, Grande E, Rodriguez-Moreno JF, Navarro P. Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01). Gynecol Oncol. 2024 Dec;191:233-239. doi: 10.1016/j.ygyno.2024.10.019. Epub 2024 Oct 24.

    PMID: 39454227DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Garcia-Donas, MD

    CIOCC (Hospital Universitario HM Sanchinarro)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 13, 2018

Study Start

April 13, 2018

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(8)