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Tykerb

Phase 1

Neoplasms, Breast | Small molecule | Oncology |GSK plc|Last Updated: Aug 31, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

Tykerb · 1 trial · 1 indication

Phase 1 1
NCT00462956GW572016 In Patients With Advanced Or Metastatic Breast CancerNeoplasms, Breast
COMPLETED59 Analytics
PHASE1COMPLETED
GW572016 In Patients With Advanced Or Metastatic Breast Cancer
Neoplasms, Breast
NCT0046295659
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Study Endpoints

Primary Endpoints

To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016

Secondary Endpoints

Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
lapatinib 1500mg dailyEXPERIMENTALSubjects will self-administer lapatinib 1500 mg orally once daily.

Interventions

NameTypeDescription
TykerbDRUGlapatinib 1500mg daily
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Eligibility Criteria

Age Range20 Years to 40 Years
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients. * Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in ...

Countries:Japan
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Frequently asked questions about Tykerb

What is Tykerb used for?

Tykerb is an investigational small molecule being studied for the treatment of neoplasms, specifically breast cancer. It is being developed by GSK plc (ticker: GSK) and is currently in Phase 1 clinical development. Tykerb is not approved and remains under investigation.

Who makes Tykerb?

Tykerb is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for the treatment of breast cancer and other neoplasms.

What phase is Tykerb in?

Tykerb is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for commercial use.

What clinical trials is Tykerb in?

Tykerb has been studied in one completed Phase 1 clinical trial, NCT00462956, titled 'GW572016 In Patients With Advanced Or Metastatic Breast Cancer'. This trial enrolled 59 female patients aged 20 years and older in Japan and was not randomized or double-blinded.

Is Tykerb FDA approved?

Tykerb is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The available data shows one completed Phase 1 trial, but no approval has been granted, and the drug remains under investigation for breast cancer.