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BGT226

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

BGT226 · 1 trial · 3 indications

Phase 1 1
NCT00600275A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast CancerSolid Tumors
COMPLETED57 Analytics
PHASE1COMPLETED
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)
throughout the study

Secondary Endpoints

Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
throughout the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BGT226EXPERIMENTAL -

Interventions

NameTypeDescription
BGT226DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion criteria: All patients * Histologically-confirmed, advanced solid tumors * Progressive, recurrent unresectable disease Phase II expansion part (advanced breast cancer) * Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression st...

Countries:United StatesCanadaSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about BGT226

What is BGT226 used for?

BGT226 is an investigational small molecule being studied for the treatment of advanced solid tumors, including advanced breast cancer and Cowden syndrome. It is in Phase 1 clinical development for these oncology indications.

Who makes BGT226?

BGT226 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is BGT226 in?

BGT226 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is BGT226 in?

BGT226 has been studied in one clinical trial, registered as NCT00600275. This was a Phase I/II study in adult patients with advanced solid malignancies, including advanced breast cancer, conducted in the United States, Canada, and Spain.

Is BGT226 the same as any other drug?

BGT226 is the primary name for this investigational compound. No alternative names have been established in the clinical trial record.