Clinical Trial: Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary

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

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

Brief Summary:

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.


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

Current Primary Outcome: Overall response rate [ Time Frame: Every 8 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical benefit [ Time Frame: Every 8 weeks ]
    Clinical benefit defined as stable disease for more than 6 months plus complete and partial response rates, measured by an external evaluator.
  • Progression-free survival [ Time Frame: Every 8 weeks ]
    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.
  • Overall survival [ Time Frame: Untill death ]
    Overall survival, defined as the time since the start of treatment until the patient dies by any cause.
  • Quality of life [ Time Frame: Every 4 weeks ]
    Quality of life measured by the validated in Spanish EORTC QLQ-C30 questionnaire.
  • Safety profile [ Time Frame: Every 4 weeks ]
    Toxicities will be classified according to the NCI-CTCAE v4.03


Original Secondary Outcome: Same as current

Information By: Grupo Español de Tumores Huérfanos e Infrecuentes

Dates:
Date Received: April 22, 2012
Date Started: October 2012
Date Completion:
Last Updated: January 19, 2015
Last Verified: January 2015