MedTrace Logo

Orteronel (TAK-700) in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors. The Greko II Study.

NCT02101684 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-03-05

No results posted yet for this study

Summary

Granulosa Cell ovarian carcinoma is an infrequent subtype of neoplasia well differentiated from epithelial tumors. They account for 5% of all ovarian malignancies and, with an incidence of 0.4-1.2 cases per 100000 habitants, is considered as a rare disease.

Though most cases are identified at initial stages and can be cured through surgical resection, distant recurrences have been documented even 10 years after resecting the primary tumor. At advanced stage it is a lethal disease.

Unfortunately because of the low incidence of this disease randomized clinical trials are lacking. In fact current evidence for treatment is provided by case reports, retrospective studies and phase II clinical trials performed one decade ago.

Orteronel, a novel, orally active, selective inhibitor of 17,20-lyase, is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as prostate cancer and breast cancer. Orteronel is expected to suppress sex hormone levels in both circulation and relevant hormone-dependent malignant tissue. Since sex hormone overproduction has been demonstrated in granulosa cell ovarian tumors and seems to play a major role in this disease, this study will assess the efficacy or orteronel treating such tumors.

Conditions

  • Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors

Interventions

DRUG

Orteronel 300mg BID

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Grupo Español de Tumores Huérfanos e Infrecuentes

    lead OTHER

Principal Investigators

  • Jesús García-Donas, MD · Hospital Universitario Madrid Sanchinarro

  • Alicia Hurtado, MD · Hospital Universitario Fundación Alcorcón

  • Juan Cueva, MD · COMPLEXO HOSPITALARIO UNIVERSITARIO DE SANTIAGO

  • Laia Garrigos, MD · Hospital del Mar

  • María Jesús Rubio, MD · COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA

  • Andrés Redondo, MD · Hospital Universitario La Paz

  • Isabel Bover, MD · Hospital Son Llatzer

  • Nuria Lainez, MD · Complejo Hospitalario de Navarra

  • Ana Santaballa, MD · Hospital Universitario La Fe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-01-11
Completion
2017-01-11

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101684 on ClinicalTrials.gov