Single-arm, Open-label, Single-center Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) for the Treatment of Patients With HER2-positive, Hormone-refractory Prostate Cancer After Failure of Treatment With Docetaxel or Ineligible for Treatment With Docetaxel
This is a phase II study of BIBW 2992 (Afatinib) in patients with hormone and chemotherapy
(docetaxel) refractory, HER2 overexpressing prostate cancer. The exploratory study following
a two stage Gehan design. In the first stage 29 patients with be treated. Additional
patients will be recruited in a second stage depending on the number of responding patients
in the first step. Patients will receive BIBW 2992 (Afatinib) orally at a dose of 50 mg
daily. Response to therapy will be scored according to PSA values (Bubley criteria) and to
CT scans (RECIST criteria). Patients will be seen at 2 or 4 weeks intervals by a medical
professional while on the medication for toxicity assessment and physical examination.
Disease evaluations will occur at baseline and every 2 months thereafter. These evaluations
will include PSA testing and CT Scans (if appropriate).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective PSA responses according to Bubley criteria
Bubley criteria see Bubley GJ, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999; 17: 3461-3467
every two months
No
Walter Fiedler, M.D:
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
Germany: Federal Institute for Drugs and Medical Devices
1200.138
NCT01320280
May 2011
November 2012
Name | Location |
---|