Clinical Trials Logo
  1. Home
  2. Refractory Cancer
  3. NCT01320280

BIBW 2992 (Afatinib) for the Treatment of Patients With HER2-positive, Hormone-refractory Prostate Cancer

Refractory Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01320280
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact
Status Terminated
Phase Phase 2
Start date May 2011
Completion date November 2012
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03336931 - PRecISion Medicine for Children With Cancer
Recruiting NCT05681195 - Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas Phase 2
Completed NCT00530192 - Molecular Profiling Protocol (SCRI-CA-001) Phase 0
Recruiting NCT05852717 - Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma Phase 2
Recruiting NCT06229340 - Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations Phase 2
Completed NCT00551850 - A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients Phase 1
Recruiting NCT06104488 - A Study of Avutometinib for People With Solid Tumor Cancers Phase 1
Terminated NCT04092179 - Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers Phase 1/Phase 2
Recruiting NCT06184035 - A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer Phase 1/Phase 2
Recruiting NCT06024603 - Individualized Treatments in Adults With Relapsed/Refractory Cancers N/A
Recruiting NCT05859074 - A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer Phase 1
Recruiting NCT05864144 - A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03187288 - Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS Phase 1
Completed NCT03441100 - TCR-engineered T Cells in Solid Tumors: IMA202-101 Phase 1
Recruiting NCT05359445 - IMA401 TCER® in Recurrent and/or Refractory Solid Tumors Phase 1
Recruiting NCT03686124 - ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors Phase 1
Recruiting NCT04337580 - Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer Phase 2
Active, not recruiting NCT04310345 - Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents N/A
Recruiting NCT05669430 - A Study of GV20-0251 in Patients With Solid Tumor Malignancies Phase 1
Not yet recruiting NCT06208657 - Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer Phase 1/Phase 2