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Report for Clinical Trial NCT02101684

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02101684 Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors
MeSH:Ovarian Neoplasms
HPO:Ovarian neoplasm

1 Interventions

Name: Orteronel 300mg BID

Type: Drug
Group Labels: 1

Orteronel 300mg b.i.d.


Primary Outcomes

Description: 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

Measure: Clinical benefit at 6 months

Time: 6 months

Secondary Outcomes

Description: Overall Response Rate according to RECIST 1.1 criteria.

Measure: Overall Response Rate

Time: Every 8 weeks, during 6 months

Description: Progression Free Survival defined as the time from the administration of the first dose of treatment to disease progression or death from any cause.

Measure: Progression free survival

Time: Every 8 weeks, during 6 months

Description: Overall Survival defined as the time from first dose of treatment to patient death from any cause

Measure: Overall Survival

Time: Every 12 weeks, untill death

Description: 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.

Measure: Reduction of sex hormones production.

Time: Every 8 weeks, during 6 months

Description: Frequency of each adverse event per patient

Measure: Toxicity profile

Time: Every 4 weeks, untill end of treatment (6 months estimated)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 C134W

- Availability of sufficient biopsy material to confirm the malignant diagnosis of granulosa cell ovarian tumor by a centralized pathologist and to perform the determine the FOXL2 402C mutation → G (C134W). --- C134W ---



HPO Nodes


HPO: