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Open Phase II Study of Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary. GreKo Study.

Phase 2
18 Years
Open (Enrolling)
Granulosa Cell Tumour of the Ovary

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Trial Information

Open Phase II Study of Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary. GreKo Study.

Inclusion Criteria:

- Patients obtained their written informed consent.

- Women ≥18 years old.

- ECOG ≤ 1.

- Histologically confirmed carcinoma of granulosa cell in ovary.

- Availability of sufficient biopsy material to confirm the diagnosis by a centralized
pathologist and determination of the FOXL2 402C mutation → G (C134W).

- Metastatic or unresectable disease.

- Imaging measurable disease.

- Life expectancy ≥ 12 weeks.

- Patients with adequate hepatic function, defined by:

- Serum values of AST and ALT ≤ 3 x UNL (except in the presence of metastases then
allowed values ≤ 5 x UNL)

- Total bilirubin ≤ 1.5 x UNL

- Patients with adequate bone marrow function, defined by:

- Absolute neutrophil count ≥ 1.5 x 10*9 / L

- Platelets ≥ 100 x 10*9 / L

- Hb > 9 g / dL

- Patients with adequate renal function: serum creatinine ≤ 1.5 x UNL.

- Absence of any impediment to comply with the study protocol.

- Women of childbearing potential, sexually active, not under hysterectomy or bilateral
adnexectomy, should follow the following guidelines on contraception:

- Negative serum or urine pregnancy test within 72 hours before the start of treatment.

- Use of a medically accepted contraceptive method during: the 2 months prior to study
treatment, during the study and 3 months after the last dose of study treatment.

Exclusion Criteria:

- Patients with another primary tumor 2 years before starting the study drug, with the
exception of cervical carcinoma in situ or adequately treated or removed completely
or basalioma or superficial bladder carcinoma.

- Patients received radical radiotherapy ≤ 4 weeks before starting the study treatment
or who have not recovered from the toxicities of radiotherapy. Palliative
radiotherapy of painful bone lesions is allowed up to 14 days before the start of
study treatment.

- Patients with heart failure or clinically significant heart disease, including any of
the following:

- History or presence of uncontrolled severe ventricular arrhythmia.

- Clinically significant bradycardia at rest.

- LVEF <45% assessed by 2-D echocardiogram (ECHO) or MUGA.

- Any of the following diseases within 6 months prior to the start of study drug:
Myocardial infarction (MI), severe or unstable angina, coronary revascularization,
congestive heart failure (CHF), stroke (CVA), transient ischemic attack (TIA).

- Patients with gastrointestinal function failure or gastric disease that significantly
alter the ketoconazole absorption, for example, severe ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption, extensive resection (> 1m) of
the small intestine or inability to swallow oral medication. The partial or total
gastrectomy is not an exclusion criteria.

- Diagnosis of infection with human immunodeficiency virus (HIV).

- Pregnant women or nursing.

- Women of childbearing potential not using effective contraceptive method.

- Patients who are unwilling or unable to comply with the protocol.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

The primary endpoint is overall response rate, defined as the proportion of patients with response defined as complete or partial response according to RECIST CRITERIA 1.1 measured by an external evaluator

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Jesus Garcia-Donas, MD

Investigator Role:

Study Director

Investigator Affiliation:

Hospital Universitario Fundación de Alcorcón, Servicio de Oncología Médica, c/ Budapest, 1,28922 Alcorcón (Madrid), Spain


Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

GETHI 2011-03



Start Date:

October 2012

Completion Date:

July 2014

Related Keywords:

  • Granulosa Cell Tumour of the Ovary
  • Granulosa Cell Tumour
  • Granulosa Cell Tumor
  • Ovarian Neoplasms