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Ovarian CancerPhase 2GREKO IIINCT03464201

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

A Phase 2 study testing Enzalutamide 40 MG in people with Ovarian Cancer, run by Grupo Español de Tumores Huérfanos e Infrecuentes at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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". Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Enzalutamide 40 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
8 sitesSpain
Study dates
13 Apr 2018to 11 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital de Mar

    Barcelona

  • Hospital Reina Sofia

    Córdoba

  • Hospital Madrid Sanchinarro (CIOCC)

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital de Navarra

    Pamplona

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital La Fe

    Valencia

Other trials in Spain

About this study

Official title: 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".

Conditions
Ovarian Cancer
Being tested
Enzalutamide 40 MG
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enzalutamide 40 MGDrug

    Enzalutamide 160 mg p.o. every day

Study groups in NCT03464201
Study groupRoleWhat they receive
EnzalutamideExperimentalEnzalutamide 160 mg daily p.o. (4 capsules 40mg per day)
Receives: Drug: Enzalutamide 40 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Number of responses according to RECIST 1.1 criteria

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Clinical benefit rate

    Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria.

    Measured: Up to 6 months

  2. Progression-free survival (PFS)

    Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause

    Measured: Up to 6 months

  3. Overall survival (OS)

    Number of deaths for any cause.

    Measured: Up to 6 months

  4. Incidence of Treatment-Emergent Adverse Events

    Number of Adverse Events per patient

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start13 Apr 2018
  3. Primary completion11 Nov 2020
  4. Study completion11 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03464201
Sponsor's protocol ID
GETHI 2016-01
Other IDs
2015-004469-10, 2015
Acronym
GREKO III
Status last verified
Feb 2023
First submitted
19 Feb 2018
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39454227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide 40 MG in people with Ovarian Cancer, run by Grupo Español de Tumores Huérfanos e Infrecuentes at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464201, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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