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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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.

Brief 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.


Detailed Summary:
Sponsor: Grupo Español de Tumores Huérfanos e Infrecuentes

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Grupo Español de Tumores Huérfanos e Infrecuentes

Dates:
Date Received: March 26, 2014
Date Started: June 2014
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017