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BAY86-9766+Gemcitabine

Phase 1

Pancreatic Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Apr 8, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

BAY86-9766+Gemcitabine · 1 trial · 1 indication

Phase 1 1
NCT01251640Combination With Gemcitabine in Advanced Pancreatic CancerPancreatic Neoplasms
COMPLETED90 Analytics
PHASE1COMPLETED
Combination With Gemcitabine in Advanced Pancreatic Cancer
Pancreatic Neoplasms
NCT0125164090
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Study Endpoints

Primary Endpoints

Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
From start of treatment until 134 weeks assessed every 8 weeks

Secondary Endpoints

Tumor Response: Investigator Assessment: Phase I
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
From start of treatment until 134 weeks assessed every 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY86-9766+GemcitabineDRUGPhase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Male or female patients ≥18 years of age * Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery * Patients must have at least one uni-dimensional measurable lesion by CT or...

Countries:United StatesBelgiumCzechiaFranceGermanyItalyNorwayPolandUnited Kingdom
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Frequently asked questions about BAY86-9766+Gemcitabine

What is BAY86-9766 used for?

BAY86-9766 is an investigational small molecule being studied for use in neoplasms, pancreatic neoplasms, and drug interactions. It has been evaluated in Phase 1 clinical trials, including as a monotherapy in Japanese patients with neoplasms and in combination with gemcitabine for advanced pancreatic cancer.

What does BAY86-9766 target?

BAY86-9766 is a small molecule developed by Bayer AG. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its potential effects in treating certain cancers, including pancreatic cancer.

Who makes BAY86-9766?

BAY86-9766 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The drug is currently in Phase 1 clinical development.

What phase is BAY86-9766 in?

BAY86-9766 is in Phase 1 clinical development. All three clinical trials associated with the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is BAY86-9766 in?

BAY86-9766 has been studied in three completed Phase 1 trials: NCT01179295, a monotherapy study in Japanese patients with neoplasms; NCT01251640, a combination study with gemcitabine in advanced pancreatic cancer; and NCT01925638, a drug interaction study with ketoconazole in healthy male volunteers.

Is BAY86-9766 the same as refametinib?

Yes, BAY86-9766 is also known as refametinib. The drug interaction trial NCT01925638 is titled 'Effect of Ketoconazole on the Pharmacokinetics of Refametinib,' confirming that refametinib is an alternative name for BAY86-9766.