The GANNET53 trial is constituted of two phases (see also “types of trials”).

PHASE I

In phase I the most efficient dose of the new therapy of ganetespib in combination with paclitaxel is examined. Approx. 9-18 patients can participate in phase I.

Objective:
To ensure the safety and tolerability of the new therapy consisting of a combination of ganetespib and the chemotherapy paclitaxel.

Duration:
All patients receive a minimum of 2 treatment cycles with the new therapy consisting of ganetespib and paclitaxel. One treatment cycle is scheduled to last for 28 days (individual changes are possible). Following these 2 treatment cycles, this therapy can be continued if it is well tolerated and has a favourable influence on the course of the disease.

PHASE II

Approx. 222 patients can participate in phase II. The patients are randomly assigned into two groups. This means that the patient cannot choose her treatment, but will be assigned to one of the two therapy groups at random.

  • Patients in group A receive the new therapy consisting of ganetespib and paclitaxel.
  • Patients in group B receive paclitaxel only, which is the standard therapy for this subgroup of ovarian cancer patients.

The ratio of the two treatment groups is 2:1. This means that the number of patients who participate in group A is twice the number of patients in group B.

Assigning patients into two groups is necessary in order to be able to compare the efficacy of the new therapy with the standard therapy.

Objective:
The objective of phase II is to determine whether it is possible to achieve an improvement in prognosis and quality of life with the new therapy compared to the standard therapy.

Duration:
The treatment can be continued as long as it is well tolerated and has a favourable influence on the course of the disease. The duration of the entire GANNET53 trial (phase I and phase II) is 5.5 years, 12 months of which will be required for phase I.