A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.
All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
Exclusion Criteria:
Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
Gainsville, Florida, United States
PORTUGALt Saint Lucie, Florida, United States
Buenos Aires, Buenos Aires, Argentina
PORTUGALto Alegre, Rio Grande Do Sul/ LA, Brazil
Kirchheim-Teck, Germany
Ny Regyh Za, HUNGARYary, Hungary
Kolkota, West Bengal, India
Cercado de Arequipa, Arequipa, Peru
Cercado, Arequipa, Peru
Warszaa, POLANDand, Poland
PORTUGALto, PORTUGALtugal, Portugal
TyGERberg, Cape Town, South Africa
Nowon-gu, Seoul, South Korea
Seodaemun-gu, Seoul, South Korea
Songpa-gu, Seoul, South Korea
TAIWANpei, TAIWANwan, Taiwan
Westgate Road, Newcastle Upon Tyne, United Kingdom