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:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Overall Response Rate according to RECIST 1.1 criteria.
- Progression free survival [ Time Frame: Every 8 weeks, during 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]Frequency of each adverse event per patient
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 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
|Contact: Jesús García-Donas, MD||(+34) email@example.com|
|Hospital Son Llatzer||Recruiting|
|Palma de Mallorca, Islas Baleares, Spain, 07198|
|Contact: Isabel Bover, MD +34 871202000 ext 1143 firstname.lastname@example.org|
|Principal Investigator: Isabel Bover, MD|
|Complexo Hospitalario Universitario de Santiago||Recruiting|
|Santiago de Compostela, La Coruña, Spain, 15706|
|Contact: Juan Cueva, MD +34 981951457 email@example.com|
|Principal Investigator: Juan Cueva, MD|
|Hospital Universitario Fundación Alcorcón||Recruiting|
|Alcorcón, Madrid, Spain, 28922|
|Contact: Alicia Hurtado, MD +34 916219490 firstname.lastname@example.org|
|Principal Investigator: Alicia Hurtado, MD|
|Complejo Hospitalario de Navarra||Recruiting|
|Pamplona/Iruña, Navarra, Spain, 31008|
|Contact: Nuria Lainez, MD +34 848422576 email@example.com|
|Principal Investigator: Nuria Lainez, MD|
|Hospital Del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Laia Garrigos, MD +34 932483137 firstname.lastname@example.org|
|Principal Investigator: Laia Garrigos, MD|
|Complejo Hospitalario Regional Reina Sofía||Recruiting|
|Córdoba, Spain, 14004|
|Contact: María Jesús Rubio, MD +34 957011420 email@example.com|
|Principal Investigator: María Jesús Rubio, MD|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Andrés Redondo, MD +34 917277516 firstname.lastname@example.org|
|Principal Investigator: Andrés Redondo, MD|
|Hospital Universitario Madrid Sanchinarro||Not yet recruiting|
|Madrid, Spain, 28050|
|Contact: Jesús García-Donas, MD +34 917567890 email@example.com|
|Principal Investigator: Jesús García-Donas, MD|
|Hospital Universitari I Politècnic La Fe||Recruiting|
|Valencia, Spain, 46026|
|Contact: Ana Santaballa, MD +34 616477116 firstname.lastname@example.org|
|Principal Investigator: Ana Santaballa, MD|
|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|