BIBW 2992 (Afatinib) for the Treatment of Patients With HER2-positive, Hormone-refractory Prostate Cancer
The purpose of this study is to find out what effects, good and/or bad, BIBW 2992 (Afatinib) has on patients and their advanced prostate cancer which does not respond to hormone or chemotherapy any more. Only patients with tumors which have an increased amounts of a protein called HER2 on their cell surface will be included.
BIBW 2992 (Afatinib) is a drug which in advanced clinical testing in lung and breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Objective PSA responses according to Bubley criteria [ Time Frame: every two months ] [ Designated as safety issue: No ]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
- Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Duration of PSA-response (Bubley criteria) or objective responses [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]Description AEs according to CTC criteria
|Study Start Date:||May 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: BIBW 2992 (Afatinib)
BIBW 2992 (Afatinib) 50mg daily continuously (oral medication)
Drug: BIBW 2992 (Afatinib)
50 mg BIBW 2992 (Afatinib) tablets daily continuously
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).
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Walter Fiedler, M.D:||Universitätsklinikum Hamburg-Eppendorf|