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Report for Clinical Trial NCT01584297

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Phase II Study of Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary. GreKo Study.

Our proposal is to conduct an open phase II clinical trial that allows us to explore the activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors similar to what has been done in prostate cancer. The rational is based on dysregulation that FOXL2 mutations present in almost all granulosa tumors result in the expression of CYP17 that appears to be key in the development and progression of the disease. This work would represent the first attempt to address the treatment of ovarian granulosa cancer with a molecular solid rational, drawing on the recent identification of the mutation "leader" of this tumor. If succeed provide a widely available therapeutic alternative compared with current cancer therapies, with low toxicity. In addition it would open a new line of research with CYP17 enzyme inhibitors that could alter the course and outcome, usually fatal, in advanced stages of disease.

NCT01584297 Granulosa Cell Tumour of the Ovary
MeSH:Granulosa Cell Tumor

1 Interventions

Name: Ketoconazole

Description: Patients will receive ketoconazole, 400 mg three times a day. Study treatment period will be during 6 months or up to progression disease, unacceptable toxicity, death or withdraw from the study for any reason.
Type: Drug
Group Labels: 1

Ketoconazole


Primary Outcomes

Description: The primary endpoint is overall response rate, defined as the proportion of patients with response defined as complete or partial response according to RECIST CRITERIA 1.1 measured by an external evaluator

Measure: Overall response rate

Time: Every 8 weeks

Secondary Outcomes

Description: Clinical benefit defined as stable disease for more than 6 months plus complete and partial response rates, measured by an external evaluator.

Measure: Clinical benefit

Time: Every 8 weeks

Description: Progression-free survival is defined as the time since the start of treatment until progressive disease assessed (through evaluation by an external radiologist) according to RECIST 1.1, or death by any cause.

Measure: Progression-free survival

Time: Every 8 weeks

Description: Overall survival, defined as the time since the start of treatment until the patient dies by any cause.

Measure: Overall survival

Time: Untill death

Description: Quality of life measured by the validated in Spanish EORTC QLQ-C30 questionnaire.

Measure: Quality of life

Time: Every 4 weeks

Description: Toxicities will be classified according to the NCI-CTCAE v4.03

Measure: Safety profile

Time: Every 4 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 C134W

- Availability of sufficient biopsy material to confirm the diagnosis by a centralized pathologist and determination of the FOXL2 402C mutation → G (C134W). - Metastatic or unresectable disease. --- C134W ---



HPO Nodes