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Lonaprisan

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |Bayer AG|Last Updated: Oct 10, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

Lonaprisan · 1 trial · 1 indication

Phase 2 1
NCT00555919ZK 230211 in Postmenopausal Woman With Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED68 Analytics
PHASE2COMPLETED
ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.
month 3, month 6

Secondary Endpoints

To evaluate safety and tolerability
ongoing thoughout the trial
To evaluate the pharmacokinetics of ZK PRA
baseline, month1,2,6
To evaluate the effect of ZK PRA on quality of life (QoL)
baseline, month 1,2,3,4,5,6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Lonaprisan (ZK 230211, BAY86-5044)DRUG25 mg daily oral treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Postmenopausal women defined as: aged \>/= 50 years with amenorrhea for at least 12 months or aged \< 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\> 40 mIU/ml) or having undergone bilateral oophorec...

Countries:AustriaFinlandFranceGermanyItalyPolandSpainSwedenSwitzerlandUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Lonaprisan

What is Lonaprisan used for?

Lonaprisan is an investigational small molecule being developed for the treatment of metastatic breast cancer. It is intended for postmenopausal women with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes Lonaprisan?

Lonaprisan is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the over-the-counter market. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic breast cancer.

What phase is Lonaprisan in?

Lonaprisan is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a controlled, randomized study involving 68 postmenopausal women with metastatic breast cancer. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is Lonaprisan in?

Lonaprisan has been studied in one clinical trial with the identifier NCT00555919. This Phase 2 trial, titled 'ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer,' was completed and enrolled 68 female participants aged 18 years and older. The study was conducted across multiple European countries.

Is Lonaprisan the same as ZK 230211?

Yes, Lonaprisan is also known as ZK 230211. The clinical trial NCT00555919 uses this alternative name in its title. This designation helps identify the drug in research databases and scientific literature related to its development for metastatic breast cancer.