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BAY79-4620

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Jan 21, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

BAY79-4620 · 1 trial · 1 indication

Phase 1 1
NCT01028755To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid TumorsNeoplasms
COMPLETED12 Analytics
PHASE1COMPLETED
To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety, tolerability, maximum tolerated dose
2 years
Pharmacokinetics profile of BAY79-4620 and its key metabolites
2 years

Secondary Endpoints

Biomarker evaluation
2 years
Tumor response
2 years
Immunogenicity
2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY79-4620DRUGBAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age greater than/equal to 18 years old. * ECOG Performance Status of 0 - 2 * Life expectancy of at least 12 weeks * Patients with advanced, histologically or cytological confirmed solid tumors, refractory to any standard therapy or have no standard therapy available * Radiogra...

Countries:United States
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Frequently asked questions about BAY79-4620

What is BAY79-4620 used for?

BAY79-4620 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being studied in patients with advanced solid tumors. As of the available data, it is in Phase 1 clinical development and has not been approved for any use.

Who makes BAY79-4620?

BAY79-4620 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development for the treatment of neoplasms, specifically advanced solid tumors.

What phase is BAY79-4620 in?

BAY79-4620 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial was designed to determine the maximum tolerated dose of BAY79-4620 in patients with advanced solid tumors. The trial has been completed.

What clinical trials is BAY79-4620 in?

BAY79-4620 has one completed clinical trial, identified as NCT01028755. This Phase 1 study was titled 'To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors.' The trial enrolled 12 participants in the United States and included adults aged 18 years and older.

Is BAY79-4620 FDA approved?

BAY79-4620 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The trial was designed to determine the maximum tolerated dose in patients with advanced solid tumors. Since it is still in early clinical development, it has not received approval for marketing or use.