Orteronel (TAK-700) in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors. The Greko II Study. (Greko II)
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.
Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors
Drug: Orteronel 300mg BID
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Open Label Phase II Clinical Trial of Orteronel (TAK-700) in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors. The Greko II Study.|
- Clinical benefit at 6 months [ Time Frame: 6 months ]Clinical benefit is defined as the average of patients with radiological response (partial or complete) plus stable disease longer than 6 months by RECIST 1.1 criteria
- Overall Response Rate [ Time Frame: Every 8 weeks, during 6 months ]Overall Response Rate according to RECIST 1.1 criteria.
- Progression free survival [ Time Frame: Every 8 weeks, during 6 months ]Progression Free Survival defined as the time from the administration of the first dose of treatment to disease progression or death from any cause.
- Overall Survival [ Time Frame: Every 12 weeks, untill death ]Overall Survival defined as the time from first dose of treatment to patient death from any cause
- Reduction of sex hormones production. [ Time Frame: Every 8 weeks, during 6 months ]Significant reduction of sex hormones production will be considered as at least a reduction to half the basal level confirmed in one determination one month apart.
- Toxicity profile [ Time Frame: Every 4 weeks, untill end of treatment (6 months estimated) ]Frequency of each adverse event per patient
|Study Start Date:||June 2014|
|Study Completion Date:||January 11, 2017|
|Primary Completion Date:||January 11, 2017 (Final data collection date for primary outcome measure)|
Experimental: Orteronel 300mg b.i.d.
Orteronel 300mg BID (600mg per day) will be administered to all included patients in a 28 days cycle schedule.
|Drug: Orteronel 300mg BID|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02101684
|Hospital Son Llatzer|
|Palma de Mallorca, Islas Baleares, Spain, 07198|
|Complexo Hospitalario Universitario de Santiago|
|Santiago de Compostela, La Coruña, Spain, 15706|
|Hospital Universitario Fundación Alcorcón|
|Alcorcón, Madrid, Spain, 28922|
|Complejo Hospitalario de Navarra|
|Pamplona/Iruña, Navarra, Spain, 31008|
|Hospital Del Mar|
|Barcelona, Spain, 08003|
|Complejo Hospitalario Regional Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Madrid Sanchinarro|
|Madrid, Spain, 28050|
|Hospital Universitari I Politècnic La Fe|
|Valencia, Spain, 46026|
|Study Director:||Jesús García-Donas, MD||Hospital Universitario Madrid Sanchinarro|
|Principal Investigator:||Alicia Hurtado, MD||Hospital Universitario Fundación Alcorcón|
|Principal Investigator:||Juan Cueva, MD||COMPLEXO HOSPITALARIO UNIVERSITARIO DE SANTIAGO|
|Principal Investigator:||Laia Garrigos, MD||Hospital del Mar|
|Principal Investigator:||María Jesús Rubio, MD||COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA|
|Principal Investigator:||Andrés Redondo, MD||Hospital Universitario La Paz|
|Principal Investigator:||Isabel Bover, MD||Hospital Son Llatzer|
|Principal Investigator:||Nuria Lainez, MD||Complejo Hospitalario de Navarra|
|Principal Investigator:||Ana Santaballa, MD||Hospital Universitario La Fe|