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Investigational Cancer Drug

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |GSK plc|Last Updated: Apr 15, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

Investigational Cancer Drug · 1 trial · 2 indications

Phase 2 1
NCT00051103Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.Metastatic Breast Cancer
COMPLETED- Analytics
PHASE2COMPLETED
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
Metastatic Breast CancerUnlock trial analytics

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Investigational Cancer DrugDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.) * Signed informed consent * No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin. * Refractory Stage IIIb or IV breast cancer * HER2/neu tum...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Investigational Cancer Drug

What is Investigational Cancer Drug used for in Metastatic Breast Cancer?

Investigational Cancer Drug is a small molecule being studied for the treatment of metastatic breast cancer. It was evaluated in a Phase 2 clinical trial in women with refractory metastatic breast cancer who had received prior first-line or second-line Herceptin therapy. The drug remains investigational and is not approved.

Who makes Investigational Cancer Drug?

Investigational Cancer Drug is being developed by GSK plc, which trades under the ticker GSK. The company sponsored a Phase 2 clinical trial of the drug in metastatic breast cancer. GSK is the developer of this investigational oncology asset.

What phase is Investigational Cancer Drug in?

Investigational Cancer Drug is in Phase 2 clinical development. It has completed one Phase 2 trial in metastatic breast cancer. The drug is investigational and has not been approved by regulatory authorities. Its development status is based on the completed Phase 2 study.

What clinical trials is Investigational Cancer Drug in?

Investigational Cancer Drug has one completed clinical trial, NCT00051103, a Phase 2 study in women with refractory metastatic breast cancer after first-line or second-line Herceptin. The trial was conducted in the United States and enrolled female patients aged 18 years and older. It was an uncontrolled, non-randomized study.

Is Investigational Cancer Drug FDA approved?

Investigational Cancer Drug is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial in metastatic breast cancer. The drug is still in clinical development and has not received marketing approval from the FDA or other regulatory agencies.