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BMS-690514

Phase 2

Breast Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 30, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

BMS-690514 · 4 trials · 4 indications

Phase 2 3Phase 1 1
NCT01167244Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior ResponseNon-Small-Cell Lung Carcinoma
COMPLETED11 Analytics
NCT01068704Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast CancerBreast Cancer
COMPLETED4 Analytics
NCT00743938A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLCNon Small Cell Lung Cancer
COMPLETED141 Analytics
PHASE2COMPLETED
Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
Non-Small-Cell Lung CarcinomaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
Breast CancerUnlock trial analytics
PHASE2COMPLETED
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
Every 8 weeks according to CT scan
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
CT/MRI at baseline and every 6 weeks for 36 weeks
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
upon occurrence

Secondary Endpoints

To estimate disease control rate and progression free survival in all treated subjects
Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To evaluate safety and tolerability of BMS-690514 in all treated subjects
Average about 10 months
Progression Free Survival: defined as time to disease progression
Every 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-690514EXPERIMENTAL -
BMS-690514 + LetrozoleACTIVE_COMPARATOR -
Lapatinib + LetrozoleACTIVE_COMPARATOR -
A1EXPERIMENTAL -
B2ACTIVE_COMPARATOR -
1EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-690514DRUGTablets, Oral, 200 mg, once daily, until disease progression or toxicity
LapatinibDRUGTablets, Oral, 1500 mg, once daily, \~ 12 months depending on response
LetrozoleDRUGTablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response
ErlotinibDRUGCapsules, Oral, 150 mg, once daily, Until disease progression or toxicity
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy. Subjects must have: * Pathologically confirmed NSCLC * Previously received treatment with single agent Gefitinib or Erlotinib and completed treatment at least 2 weeks prior to study entry * Any ...

Countries:JapanUnited StatesArgentinaMexicoPeruCanadaFrancePolandSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials

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 BMS-690514

What is BMS-690514 used for?

BMS-690514 is an investigational small molecule being studied for the treatment of non-small-cell lung carcinoma, breast cancer, and other solid tumors. It is being developed by Bristol-Myers Squibb Company and has reached Phase 2 clinical development for these oncology indications.

What does BMS-690514 target?

BMS-690514 is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here.

Who makes BMS-690514?

BMS-690514 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker BMY. The drug is an investigational small molecule in clinical development for oncology indications.

What phase is BMS-690514 in?

BMS-690514 is in Phase 2 clinical development for non-small-cell lung carcinoma, breast cancer, and other solid tumors. It is investigational and not yet approved by regulatory authorities. All completed clinical trials for the drug are Phase 1 studies.

What clinical trials is BMS-690514 in?

BMS-690514 has been studied in several completed Phase 1 trials, including NCT00329004 in advanced solid tumors, NCT00420186 with paclitaxel and carboplatin, NCT00479583 with FOLFIRI and FOLFOX, and NCT00516451 in Japanese patients with solid tumors. These trials enrolled a total of 141 participants.

Is BMS-690514 the same as any other drug?

No alternative names for BMS-690514 have been reported. The drug is identified solely by its code name BMS-690514 in clinical trial records and development information.