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BMS-690514/ FOLFIRI

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 30, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials3
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

BMS-690514/ FOLFIRI · 3 trials · 2 indications

Phase 1 3
NCT00516451Phase I Study of BMS-690514 in Japanese Patients With Solid TumorsCancer
COMPLETED9 Analytics
NCT00479583Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOXCancer
COMPLETED25 Analytics
NCT00329004A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid TumorsCancer
COMPLETED89 Analytics
PHASE1COMPLETED
Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors
CancerUnlock trial analytics
PHASE1COMPLETED
Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
CancerUnlock trial analytics
PHASE1COMPLETED
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514
administered orally every day 28 days
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

Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.
throughout the study
Safety evaluations and laboratory assessments will be performed
throughout the study
Preliminary markers of efficacy will also be assessed
throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BMS-690514DRUGTablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more
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 Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Countries:JapanUnited StatesFranceCanadaSpain
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Frequently asked questions about BMS-690514/ FOLFIRI

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.