drugset / Trial / NCT01320280
BIBW 2992 (Afatinib) for the Treatment of Patients With HER2-positive, Hormone-refractory Prostate Cancer
Phase 2
Terminated
29 enrolled
University Medical Center Hamburg-Eppendorf
Boehringer Ingelheim · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-11
- Completion
- 2012-11
Publications
- Background Yap TA, Vidal L, Adam J, Stephens P, Spicer J, Shaw H, Ang J, Temple G, Bell S, Shahidi M, Uttenreuther-Fischer M, Stopfer P, Futreal A, Calvert H, de Bono JS, Plummer R. Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors. J Clin Oncol. 2010 Sep 1;28(25):3965-72. doi: 10.1200/JCO.2009.26.7278. Epub 2010 Aug 2.
- Results Minner S, Jessen B, Stiedenroth L, Burandt E, Kollermann J, Mirlacher M, Erbersdobler A, Eichelberg C, Fisch M, Brummendorf TH, Bokemeyer C, Simon R, Steuber T, Graefen M, Huland H, Sauter G, Schlomm T. Low level HER2 overexpression is associated with rapid tumor cell proliferation and poor prognosis in prostate cancer. Clin Cancer Res. 2010 Mar 1;16(5):1553-60. doi: 10.1158/1078-0432.CCR-09-2546. Epub 2010 Feb 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 50 mg | Oral |