CLINICAL TRIALS

Within the EU project GANNET53 two different clinical trials are conducted which are accompanied by companion diagnostics activities, translational research and the establishment of an extensive biobank.

  • The first clinical trial is the GANNET53 CLINICAL TRIAL consisting of a Phase I and a Phase II trial. The GANNET53 trial is a Europe-wide multi-centre clinical trial, involving national trial groups to safeguard sufficient enrolment of patients. Recruitment in the GANNET53 Phase II clinical trial was closed in September 2016.
  • The EUDARIO CLINICAL TRIAL is a European, multi-center, randomised three-arm open-label Phase II trial in mutp53, platinum-sensitive ovarian cancer patients. It evaluates the safety and efficacy of Ganetespib in combination with Carboplatin on one hand and the Poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor Niraparib on the other hand in comparison to standard treatment options. THE EUDARIO CLINICAL TRIAL IS CURRENTLY OPEN FOR RECRUITMENT.

EUDARIO Clinical Trial

The objectives of the EUDARIO trial are

  • define safety of Ganetespib in combination with Carboplatin in platinum-sensitive ovarian cancer patients in the EUDARIO trial;
  • define safety of Ganetespib in a new combination with the PARPi Niraparib in the EUDARIO trial;
  • determine EFFICACY in the EUDARIO trial
  • collect biomaterials for molecular efficacy testing of Ganetespib and for p53 status analysis

The EUDARIO trial is an open label three-arm randomised Phase II study where the efficacy of Ganetespib 150mg/m2 in combination with Carboplatin AUC5 followed by maintenance treatment with the PARPi Niraparib (+/- Ganetespib in arms B and C, respectively) is compared versus standard Carboplatin combination treatment (investigator`s choice: Carboplatin puls Gemcitabine or Carboplatin plus Paclitaxel, respectively) followed by maintenance treatment with Niraparib in platinum-sensitive ovarian cancer patients.

EUDARIO Patient Recruitment Strategy

The EUDARIO trial is also a Europe-wide multi-centre clinical trial, involving national trial groups to safeguard sufficient and fast enrolment of patients. The EUDARIO trial will be open in Belgium, Austria, Germany, France and Italy via the respective national trial groups.

The national trial groups are:

  1. A-AGO (Austrian Gynaecological Oncology Trial Group) with its trial centre at Innsbruck Medical University (P1)
  2. NOGGO (North-Eastern German Society of Gynaecological Oncology; P9)
  3. GINECO (Groupe d’Investigateurs Nationaux pour l’Étude des Cancers Ovariens et du Sein; P10)
  4. BGOG (Belgium and Luxembourg Gynaecological Oncology Group) with its trial center at KU Leuven (P2)
  5. MITO (Multicenter Italian Trials in Ovarian cancer and gynaecologic malignancies; P20)

BGOG trial centre is the legal sponsor and the lead trial group of the EUDARIO trial.

All core competences related to the performance of clinical trials are available in the BGOG trial centre and the national trial groups. With this concept we avoid the inclusion of for-profit service providers.


GANNET53 Clinical Trial

In the GANNET53 Clinical Trial (EUDRACT Number: 2013-003868-31) women with platinum-resistant, high-grade serous, high-grade endometrioid, or undifferentiated epithelial ovarian, fallopian tube or primary peritoneal cancer were addressed.

The aim of the GANNET53 trial was to combat metastatic platinum-resistant ovarian cancer with a novel drug strategy that targets the central driver of aggressiveness and metastatic ability of epithelial ovarian cancers, namely stabilised mutant p53 protein, for degradation via an innovative Hsp90 (heat shock protein 90) inhibition mechanism in order to substantially improve SURVIVAL.

The main target of this GANNET53 drug strategy is a central driver of tumour aggressiveness and metastatic ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition mechanism. The most advanced, second-generation Hsp90 inhibitor is used, Ganetespib.

In the first part (Phase I) of the GANNET53 trial the safety of Ganetespib in a new combination with standard chemotherapy (Paclitaxel weekly) was tested in high-grade serous, high-grade endometrioid or undifferenciated, platinum-resistant ovarian cancer patients. In the second part (randomised Phase II) the efficacy of Ganetespib in combination with standard chemotherapy versus standard chemotherapy alone was examined in this group of ovarian cancer patients.

The GANNET53 Clinical Trial was closed in September 2016.

GANNET53 Phase I

GANNET53 Phase II

Description of work