TAK-700 in Castration Resistant Prostate Cancer
The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.|
- The primary endpoint of the trial is clinical progression free survival. [ Designated as safety issue: No ]The primary endpoint of the trial is clinical progression free survival. In this protocol, it is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group 2" and referred to as the "PCWG2" for the setting "delay/prevent" progression.
- RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease [ Designated as safety issue: No ]
- Time to PSA (Prostate specific antigen) progression and PSA change from baseline [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Safety according to Common Terminology Criteria for Adverse Events, version 4.03 [ Designated as safety issue: Yes ]
- Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia [ Designated as safety issue: No ]
- Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone [ Designated as safety issue: No ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Experimental: Orteronel, 300 mg twice daily||
Tak-700 will be administered until disease progression, diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.
Upon progression, patient may stay on study medication until the initiation of a new therapy
Other Name: TAK 700
|Active Comparator: Bicalutamide 50 mg per day||
Bicalutamide will be given at the standard daily dose of 50 mg PO (per os). Bicalutamide will be maintained until disease progression diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.
|Contact: Julie Hermans, PhDfirstname.lastname@example.org|
|Principal Investigator:||Cora Sternberg||San Camillo Forlanini Hospitals, Rome, Italy|
|Study Chair:||Bertrand Tombal||Cliniques Universitaires de St Luc, Brussels, Belgium|