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

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



Sponsors


Source

Grupo Español de Tumores Huérfanos e Infrecuentes

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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".

Overall Status

Recruiting

Start Date

2018-04-13

Completion Date

2020-03-01

Primary Completion Date

2020-03-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Overall response rate (ORR)
Up to 6 months

Secondary Outcome

Measure

Time Frame

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

Enrollment

35

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Enzalutamide 160 mg p.o. every day

Arm Group Label

Enzalutamide


Eligibility

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.

Gender

Female

Gender Based

Yes

Gender Description

Due to kind of disease only female patients are acceptable for the trial

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Garcia-Donas, MD
Principal Investigator
CIOCC (Hospital Universitario HM Sanchinarro)

Overall Contact

Last Name

Ana Moreno

Phone

+34 91 816 68 04

Email

ana.moreno@apices.es


Location

Facility

Status

Hospital de Mar
Barcelona Spain
Recruiting
Hospital Reina Sofia
Córdoba Spain
Recruiting
Hospital Madrid Sanchinarro (CIOCC)
Madrid Spain
Recruiting
Last Name: Garcia-Donas, MD
Phone: +34 91 756 79 84
Email: jgarciadonas@gmail.com
Hospital Universitario La Paz
Madrid Spain
Recruiting
Hospital Son Llatzer
Palma De Mallorca Spain
Recruiting
Hospital de Navarra
Pamplona Spain
Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago De Compostela Spain
Recruiting
Hospital La Fe
Valencia Spain
Not yet recruiting

Location Countries

Country

Spain


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Enzalutamide

Arm Group Type

Experimental

Description

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


Firstreceived Results Date

N/A

Acronym

GREKO III

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

February 19, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

May 10, 2018

Last Update Submitted Qc

May 10, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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