Patients with HER2-positive, hormone-refractory prostate cancer after failure of treatment with docetaxel or ineligible for treatment with docetaxel. MedDRA version: 13.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Patients must provide written informed consent •Age = 18 years •Patients must have histological proven, hormone-refractory prostate cancer •Patients must have failed prior therapy with docetaxel or must be ineligible for treatment with docetaxel •Patients must have ECOG performance status = 2 •Patients must not have received any prior therapy targeting EGFR or HER2 •Patients must have adequate bone marrow, renal and hepatic function •Patients must not have a history of severe heart disease •Patients must not have had a myocardial infarction within the previous six months •Patients must have normal left ventricular ejection fraction (LVEF = normal limit of institution) •Patients must not have symptomatic brain or leptomeningeal metastatic disease •Patients must have recovered from previous treatment-related adverse effects to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade = 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: •Prior treatment with EGFR/HER2-targeted small molecules or antibodies, i.e. trastuzumab and/or lapatinib •Known pre-existing interstitial lung disease •Radiotherapy, chemotherapy, hormone therapy (with the exception of GnRH agonists), immunotherapy or surgery (other than biopsy) within 4 weeks prior to start of treatment with BIBW2992. GnRH-agonists are allowed at the discretion of the investigator. •Active brain metastases (defined as stable for 1.5 times upper limit of normal. •Uncontrolled hypercalcemia •Patients unable to comply with the protocol. •Known hepatitis B infection, known hepatitis C infection or known HIV carrier. •Known or suspected active drug or alcohol abuse. •Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1 of the protocol. •Any contraindications for therapy with BIBW 2992. •Known hypersensitivity to BIBW 2992. •Use of any investigational drug within 4 weeks of start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in this patient population. If this study shows promising results, further studies to evaluate the benefit of BIBW 2992 in this subgroup of HER2-positive patients with hormone-refractory prostate cancer are warranted.;Secondary Objective: none;Primary end point(s): PSA response rate according to Bubley criteria of BIBW 2992 in patients with hormone refractory prostate cancer after failure of docetaxel chemotherapy. ;Timepoint(s) of evaluation of this end point: PSA should be determined at screening, visit 1 of every other cycle, EOT, and Follow-up 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Germany
Contacts
Public ContactClinical Trial Informations
Clinical Trial Center North, Medigate GmbH
Outcome results
None listed