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BAY59-8862

Phase 2

Breast Neoplasms | Small molecule | Oncology |Bayer AG|Trials Updated: Dec 23, 2014

BAY59-8862 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2002

BAY59-8862 target and mechanism

ModalitySmall molecule

Also known as BAY59-8862 (Cytotoxic Taxane)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment238

FDA Designations

No designations recorded

BAY59-8862 clinical trials

BAY59-8862 · 3 trials · 4 indications

Phase 2 3
NCT00044525Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer PatientsBreast Neoplasms
COMPLETED82 Analytics
NCT00044538Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer PatientsCarcinoma, Non-Small-Cell Lung
COMPLETED102 Analytics
NCT00044564Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell CarcinomaCarcinoma, Renal Cell
COMPLETED54 Analytics
PHASE2COMPLETED
Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
Breast NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients
Carcinoma, Non-Small-Cell LungUnlock trial analytics
PHASE2COMPLETED
Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Carcinoma, Renal CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
At baseline and every 2 cycles during the treatment period

Secondary Endpoints

Duration of response
At baseline and every cycle during the treatment period
Overall survival
Till end of follow up period (up to 2 years)
Time to progression
Throughout study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY59-8862 (Cytotoxic Taxane)DRUG1 h intravenous infusion every 3 weeks
Bay 59-8862DRUG75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Female patients with a proven diagnosis of metastatic breast cancer * Measurable disease as defined by the presence of at least one measurable lesion * Patients must have received at least 3 weeks of continuous therapy with Taxane * patient must subsequently develop progressiv...

Countries:GermanyGreeceIsraelItalyPolandSwitzerlandUnited KingdomUnited StatesCanadaSpainFranceNetherlands
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Frequently asked questions about BAY59-8862

What is BAY59-8862?

BAY59-8862 is an investigational small molecule oncology drug developed by Bayer AG. It is also known as a cytotoxic taxane and has been studied under the names Bay 59-8862 and BAY 59-8862. It was evaluated in Phase 2 clinical trials for several advanced solid tumors, including breast cancer, non-small cell lung cancer, and renal cell carcinoma.

What is BAY59-8862 used for?

BAY59-8862 was studied for the treatment of advanced solid tumors, specifically metastatic breast cancer, taxane-resistant non-small cell lung cancer, and advanced renal cell carcinoma. It is an investigational agent and is not approved for any indication. All clinical trials of BAY59-8862 have been completed.

Who makes BAY59-8862?

BAY59-8862 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 2 clinical trials evaluating the drug in breast cancer, non-small cell lung cancer, and renal cell carcinoma.

What phase is BAY59-8862 in?

BAY59-8862 is in Phase 2 development. It has completed Phase 2 trials in metastatic breast cancer, taxane-resistant non-small cell lung cancer, and advanced renal cell carcinoma. No active trials are currently recruiting, and the drug is investigational and not approved for any indication.

What clinical trials is BAY59-8862 in?

BAY59-8862 has been evaluated in three completed Phase 2 trials: NCT00044564 in advanced renal cell carcinoma, NCT00044538 in taxane-resistant non-small cell lung cancer, and NCT00044525 in taxane-resistant metastatic breast cancer. These studies enrolled patients across North America, Europe, and Israel.

Is BAY59-8862 the same as Bay 59-8862?

Yes, BAY59-8862 is the same as Bay 59-8862 and BAY 59-8862. These are alternative names for the same investigational cytotoxic taxane developed by Bayer AG. The different spellings and capitalizations refer to the identical drug candidate studied in Phase 2 oncology trials.