Clinical Trial

Phase I

Objectives

  • define safety of Ganetespib in a new combination with the taxane Paclitaxel

Description of Work

Phase II

Objectives

  • determine efficacy of the combination of Ganetespib and Paclitaxel weekly in comparison to Paclitaxel weekly alone in patients with platinum resistant high grade serous or high grade endometrioid or undifferentiated ovarian cancer
  • further define safety of Ganetespib in combination with the taxane Paclitaxel
  • collect biomaterials for molecular efficacy testing of Ganetespib and for p53 status analysis

Description of Work

Important Update on Patient Recruitment for Phase II

Based on the recommendation of the Data and Safety Monitoring Committee, the Steering Committee of the GANNET53 consortium decided on 21 September 2016 to stop the recruitment of new patients in the GANNET53 trial.

More information

Patient Recruitment Strategy

The GANNET53 trial is a Europe-wide multi-centre clinical trial, involving national trial groups to safeguard sufficient enrolment of patients.

The GANNET53 trial will be open nation-wide in Austria, Germany and France via the respective national trial groups and at the high-volume University Centre Leuven in Belgium.

Recruitment concept of the GANNET53 trial

National trial groups include:

  1. A-AGO (Austrian Gynaecological Oncology Trial Group) with its trial centre at Innsbruck Medical University (P1 covering Austria)
  2. G-AGO (German Gynaecological Oncology Trial Group; P8) covering mainly western Germany
  3. NOGGO (North-Eastern German Society of Gynaecological Oncology; P9) covering north-eastern Germany
  4. GINECO (Groupe d’Investigateurs Nationaux pour l’Étude des Cancers Ovariens et du Sein; P10) covering France

Translational Research

Biobank

Objectives

  • Develop a database for biosample collection (virtual tumour bank) and biosample tracking
  • Organise prospective and retrospective collection, deposition and delivery of biomaterials
  • Provide Central Histopathological Review (CHR) to ensure the inclusion of solely Type II tumours into Phase II and to ensure tissue sample quality for experimental work

Description of Work


Companion Diagnostics

Objectives

  • Determine the exact p53 status in Phase II patients
  • Perform molecular efficacy testing: (1) a functional molecular test (proximity ligation assay) will be developed and evaluated for its value to predict responsiveness to Ganetespib. (2) CTC analysis before and during experimental therapy will be performed and evaluated for its value to monitor responsiveness to Ganetespib.

Mouse Models and Human Xenografts

Objectives

  • Provide the most stringent in vivo genetic and pharmacologic proof-of-principle for the underlying treatment concept in engineered mutp53 knock-in mice.
  • Stringently test the Ganetespib-mediated preferential killing of mutp53 cancer cells in human ovarian cancer models (cultured cells and nude mice).