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Bay 59-8862

Phase 2

Carcinoma, Renal Cell | Small molecule | Oncology |Bayer AG|Last Updated: Dec 19, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Bay 59-8862 · 1 trial · 1 indication

Phase 2 1
NCT00044564Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell CarcinomaCarcinoma, Renal Cell
COMPLETED54 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
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
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow,...

Countries:United StatesCanadaFranceGermanyNetherlandsUnited Kingdom
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Frequently asked questions about Bay 59-8862

What is BAY59-8862 used for?

BAY59-8862 is an investigational small molecule being studied for the treatment of breast cancer, non-small-cell lung cancer, and renal cell carcinoma. It has been evaluated in Phase 2 clinical trials for these oncology indications, including taxane-resistant metastatic breast cancer and taxane-resistant non-small-cell lung cancer.

Who makes BAY59-8862?

BAY59-8862 is being developed by Bayer AG, a German pharmaceutical company. Bayer AG trades on the OTC market under the ticker symbol BAYRY. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is BAY59-8862 in?

BAY59-8862 is in Phase 2 clinical development. It has completed three Phase 2 trials, one each in breast cancer, non-small-cell lung cancer, and renal cell carcinoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BAY59-8862 in?

BAY59-8862 has completed three Phase 2 trials: NCT00044525 in taxane-resistant metastatic breast cancer with 82 patients, NCT00044538 in taxane-resistant non-small-cell lung cancer with 102 patients, and NCT00044564 in advanced renal cell carcinoma with 54 patients. All trials are completed.

Is BAY59-8862 FDA approved?

BAY59-8862 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for breast cancer, non-small-cell lung cancer, and renal cell carcinoma. The drug remains in clinical development and has not received marketing approval.