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BAY1179470

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Sep 14, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

BAY1179470 · 1 trial · 1 indication

Phase 1 1
NCT01881217First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid TumorsNeoplasms
COMPLETED35 Analytics
PHASE1COMPLETED
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Up to 2 years
Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days

Secondary Endpoints

Tumor response
Every 42 days
Biomarker (plasma)
Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
Biomarker (biopsy)
Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY1179470 (Dose escalation)EXPERIMENTALBAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
BAY1179470 (additional)EXPERIMENTALAdditional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
BAY1179470 (expansion)EXPERIMENTALExpansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Interventions

NameTypeDescription
BAY1179470DRUGBAY1179470 will be administered as a 1-hour intravenous infusion.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard * Eastern Cooperative Oncology Group (ECOG) perfor...

Countries:JapanSingaporeSouth Korea
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Frequently asked questions about BAY1179470

What is BAY1179470 used for?

BAY1179470 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed for patients with advanced, refractory solid tumors, meaning tumors that have not responded to prior treatments.

Who makes BAY1179470?

BAY1179470 is being developed by Bayer AG, a German multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is BAY1179470 in?

BAY1179470 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing.

What clinical trials is BAY1179470 in?

BAY1179470 has been studied in one clinical trial, identified as NCT01881217. This was a first-in-man dose escalation study in patients with advanced, refractory solid tumors. The trial was conducted in Japan, Singapore, and South Korea, enrolled 35 participants, and has been completed.

Is BAY1179470 the same as any other drug?

BAY1179470 is the only name provided for this investigational drug. No alternative names or aliases have been reported for this compound. It is a distinct small molecule being developed by Bayer AG for the treatment of neoplasms.