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BMS-690514/ FOLFIRI

Phase 2

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

BMS-690514/ FOLFIRI target and mechanism

Molecular targetERBB4, EGFR, ERBB2, FLT1, FLT4, KDR
Target classInhibitor
ModalitySmall molecule

Also known as BMS-690514

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials7
Total Enrollment316

FDA Designations

No designations recorded

BMS-690514/ FOLFIRI clinical trials

BMS-690514/ FOLFIRI · 7 trials · 6 indications

Phase 2 3Phase 1 4
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 determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514
administered orally every day 28 days
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
upon occurrence
Safety assessment
throughout the study
dose-limiting toxicity (DLT)
assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Safety
results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated
continuous medical review of adverse event reports

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 -
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -

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
BMS-690514 / FOLFIRIDRUGTablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
BMS-690514 / FOLFOXDRUGTablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
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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 609 trials

Frequently asked questions about BMS-690514/ FOLFIRI

What is BMS-690514/FOLFIRI?

BMS-690514/FOLFIRI refers to the investigational small molecule BMS-690514 evaluated in combination with FOLFIRI chemotherapy. BMS-690514 was developed by Bristol-Myers Squibb Company (BMY) and studied in solid tumors, including non-small cell lung cancer and breast cancer. It remains an investigational agent and is not approved for any indication.

What does BMS-690514 target?

BMS-690514 targets EGFR, ERBB2, ERBB4, KDR, FLT1, and FLT4. It is a small molecule inhibitor of these receptor tyrosine kinases, which are involved in tumor cell proliferation and angiogenesis. This multi-target profile distinguishes it from agents that inhibit only EGFR.

Who makes BMS-690514/FOLFIRI?

Bristol-Myers Squibb Company (ticker: BMY) developed BMS-690514. The FOLFIRI component is a standard chemotherapy regimen, not a proprietary product of Bristol-Myers Squibb. Bristol-Myers Squibb sponsored the clinical trials of BMS-690514, including the combination studies.

What phase is BMS-690514 in?

BMS-690514 is in Phase 2 development. Four clinical trials have been completed, including Phase 1 and Phase 2 studies, with no active trials ongoing. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is BMS-690514 in?

BMS-690514 has been studied in four completed trials: NCT01167244 in EGFR mutation positive non-small cell lung cancer in Japan, NCT01068704 with letrozole in metastatic breast cancer, NCT00743938 comparing BMS-690514 with erlotinib in previously treated NSCLC, and NCT00516451 in Japanese patients with solid tumors.