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BMS-906024

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Jan 28, 2020

BMS-906024 development status

Highest phase Phase 1
Registered trials 5 across 2 sponsors since Dec 2004

BMS-906024 target and mechanism

ModalitySmall molecule

Also known as Notch inhibitor, BMS-906024 (Notch inhibitor)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials3
Total Enrollment266

FDA Designations

No designations recorded

BMS-906024 clinical trials

BMS-906024 · 3 trials · 3 indications

Phase 1 3
NCT01653470Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid TumorsCancer
COMPLETED141 Analytics
NCT01363817Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaLymphoblastic Leukemia, Acute T-cell
COMPLETED31 Analytics
NCT01292655Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid TumorsCancer
COMPLETED94 Analytics
PHASE1COMPLETED
Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors
CancerUnlock trial analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Lymphoblastic Leukemia, Acute T-cellUnlock trial analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Up to 30 days after the last dose of study medication
Number of subjects with adverse events as a measure of safety and tolerability
Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin
16 time points up to first 3 cycles
Trough observed plasma concentration (Cmin) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin
16 time points up to first 3 cycles
Time of maximum observed plasma concentration (Tmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin
16 time points up to first 3 cycles
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: Paclitaxel + BMS-906024EXPERIMENTALPaclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024EXPERIMENTAL5FU Bolus 400 mg/m2, 5FU Infusion 2400 mg/m2, Irinotecan 180 mg/m2 solution, Leucovorin 400 mg/m2 solution intravenously once every 2 weeks and BMS- 906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
Arm C: Carboplatin/Paclitaxel + BMS-906024EXPERIMENTALCarboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once weekly intravenously continuously until disease progression or unacceptable toxicity
Arm D: Paclitaxel + BMS-906024EXPERIMENTALPaclitaxel 80 mg/m2 solution once weekly and BMS-906024 4 mg or 6 mg solution once every 2 weeks intravenously continuously until disease progression or unacceptable toxicity
Arm F: Carboplatin/Paclitaxcel and BMS-906024EXPERIMENTALCarboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once every 3 weeks intravenously continuously until disease progression or unacceptable toxicity
Escalation Phase: BMS-906024EXPERIMENTALBMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity
Expansion Phase: BMS-906024 + DexamethasoneEXPERIMENTALBMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity
Arm A1 (Escalation): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm A2 (Expansion): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm B1 (Escalation): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm B2 (Expansion): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified

Interventions

NameTypeDescription
PaclitaxelDRUG -
5-Fluorouracil (5FU)DRUG -
CarboplatinDRUG -
LeucovorinDRUG -
IrinotecanDRUG -
BMS-906024DRUG -
DexamethasoneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate * Subjects with non-small cell lung cancer and triple-negative br...

Countries:United StatesBelgiumCanadaFranceGermanyAustralia
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about BMS-906024

What is BMS-906024?

BMS-906024 is an investigational small molecule developed by Bristol-Myers Squibb for the treatment of cancer. It has been studied in advanced or metastatic solid tumors and in acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma. It remains in clinical development and is not an approved therapy.

What is BMS-906024 used for in cancer?

BMS-906024 has been studied in adults with advanced or metastatic solid tumors and in adults with acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Trials evaluated it both as a single agent and in combination with chemotherapy regimens including weekly paclitaxel, 5FU plus irinotecan, and carboplatin plus paclitaxel.

Who makes BMS-906024?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-906024. The company sponsored the clinical trials evaluating the compound in solid tumors and in T-cell lymphoblastic leukemia and lymphoma.

What phase is BMS-906024 in?

BMS-906024 is in Phase 1 clinical development. Both of its listed Phase 1 trials have been completed, and no trials are currently active. It is an investigational agent and has not been approved by the FDA for any indication.

What clinical trials is BMS-906024 in?

BMS-906024 was evaluated in Phase 1 trials NCT01653470, which tested it with chemotherapy in advanced or metastatic solid tumors, NCT01363817, which studied weekly intravenous doses in acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, and NCT01292655, which studied intravenous doses in advanced or metastatic solid tumors.

How many patients were enrolled in BMS-906024 trials?

Across its completed Phase 1 studies, BMS-906024 enrolled a total of 235 participants. NCT01653470 enrolled 141 patients, NCT01292655 enrolled 94 patients, and NCT01363817 enrolled 31 patients. All trials enrolled adults aged 18 years and older and were conducted at sites in the United States, Canada, and Europe.