check_circleStudy Completed
Metastatic breast cancer
Bayer Identifier:
91484
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
ZK 230211 in postmenopausal woman with metastatic breast cancer
Trial purpose
Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.
Key Participants Requirements
Sex
FemaleAge
18 YearsTrial summary
Enrollment Goal
68Trial Dates
March 2008 - March 2011Phase
Phase 2Could I Receive a placebo
NoProducts
Lonaprisan (Antiprogestin, BAY86-5044)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | SMZ Süd- Kaiser- Franz- Josef- Spital | Wien, 1100, Austria |
Completed | Klinikum der Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | IRCCS Ist Clinico Humanitas | Rozzano, 20089, Italy |
Completed | Universität Erlangen-Nürnberg | Erlangen, 91054, Germany |
Completed | Centre René Gauducheau | Nantes, 44805, France |
Completed | Centre Oscar Lambret | Lille, 59020, France |
Completed | Hôpital Tenon - Paris | Paris, 75020, France |
Completed | Nottingham City Hospital | Nottingham, NG5 1PB, United Kingdom |
Completed | SP Szpital Kliniczny nr 2 | Poznan, 60-569, Poland |
Completed | NZOZ ONKO-MED | Olsztyn, 10-226, Poland |
Completed | Växjö Centrallasarett | Växjö, 351 85, Sweden |
Completed | Länssjukhuset Sundsvall-Härnösand | Sundsvall, 851 86, Sweden |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Completed | Universitätsklinikum Innsbruck | Innsbruck, 6020, Austria |
Completed | Kantonsspital St. Gallen | St. Gallen, 9007, Switzerland |
Completed | Klinikum der Christian-Albrechts-Universität | Kiel, 24105, Germany |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | Landeskrankenhaus Salzburg | Salzburg, 5020, Austria |
Completed | Klinikum Südstadt | Rostock, 18059, Germany |
Completed | Centre Val d'Aurelle - Montpellier | MONTPELLIER, 34000, France |
Completed | Institut Jean Godinot - CRLCC | Reims, 51056, France |
Completed | Centre Léon Bérard | LYON CEDEX, 69008, France |
Completed | Wojewodzkie Centrum Onkologii | Gdansk, 80-219, Poland |
Completed | Centrum Medyczne "Dojlidy" | Bialystok, 15-540, Poland |
Completed | Vaasan keskussairaala | Vaasa, 65130, Finland |
Completed | Turun yliopistollinen keskussairaala, kantasairaala | Turku, FIN-20521, Finland |
Primary Outcome
- To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.date_rangeTime Frame:month 3, month 6enhanced_encryptionnoSafety Issue:
Secondary Outcome
- To evaluate safety and tolerabilitydate_rangeTime Frame:ongoing thoughout the trialenhanced_encryptionyesSafety Issue:
- To evaluate the pharmacokinetics of ZK PRAdate_rangeTime Frame:baseline, month1,2,6enhanced_encryptionnoSafety Issue:
- To evaluate the effect of ZK PRA on quality of life (QoL)date_rangeTime Frame:baseline, month 1,2,3,4,5,6enhanced_encryptionnoSafety Issue:
- To perform exploratory analysis of biomarkersdate_rangeTime Frame:baseline, month 1, 3enhanced_encryptionnoSafety Issue:
- Progression-free survival (PFS)date_rangeTime Frame:end of studyenhanced_encryptionnoSafety Issue:
- Objective response rate (ORR) / Duration of response - in the subset of patients with measurable diseasedate_rangeTime Frame:end of studyenhanced_encryptionnoSafety Issue:
- Duration of Clinical Benefitdate_rangeTime Frame:end of studyenhanced_encryptionnoSafety Issue:
- Overall Survival (OS)date_rangeTime Frame:end of studyenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2