Trials / Terminated
TerminatedNCT02012192
GANNET53: Ganetespib in Metastatic, p53-mutant, Platinum-resistant Ovarian Cancer
A Two-part, Multicentre, International Phase I and II Trial Assessing the Safety and Efficacy of the Hsp90 Inhibitor Ganetespib in Combination With Paclitaxel Weekly in Women With High-grade Serous, High-grade Endometrioid, or Undifferentiated, Platinum-resistant Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Medical University Innsbruck · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900 deaths annually in Europe. The predominance of aggressive Type II tumours, which are characterised by a high frequency of p53 mutations, and primary or acquired resistance to platinum-based chemotherapy profoundly contribute to the high mortality rate. With current standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian cancer patients is only 14 month. There is a pressing need for more effective, innovative treatment strategies to particularly improve survival in this subgroup of EOC patients. This is a drug strategy targeting 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 will be used, Ganetespib. The first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second part (randomised Phase II) will examine the efficacy of Ganetespib in combination with standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ganetespib | |
| DRUG | Paclitaxel |
Timeline
- Start date
- 2014-07-04
- Primary completion
- 2017-11-30
- Completion
- 2017-12-04
- First posted
- 2013-12-16
- Last updated
- 2019-08-13
- Results posted
- 2019-08-13
Locations
10 sites across 4 countries: Austria, Belgium, France, Germany
Source: ClinicalTrials.gov record NCT02012192. Inclusion in this directory is not an endorsement.