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MSC2490484A

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Merck KGaA|Last Updated: Apr 28, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

MSC2490484A · 1 trial · 2 indications

Phase 1 1
NCT02316197Clinical Phase I Study Investigating MSC2490484A, an Inhibitor of a DNA-dependent Protein Kinase, in Advanced Solid Tumors or Chronic Lymphocytic LeukemiaAdvanced Solid Tumors
COMPLETED31 Analytics
PHASE1COMPLETED
Clinical Phase I Study Investigating MSC2490484A, an Inhibitor of a DNA-dependent Protein Kinase, in Advanced Solid Tumors or Chronic Lymphocytic Leukemia
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Dose limiting toxicities (DLTs) occurring in Cycle 1
up to Day 21 of Cycle 1

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Day 1 of Cycle 1 (cycle length = 21 days)
Time to Maximum Observed Plasma Concentration (tmax)
Day 1 of Cycle 1 (cycle length = 21 days)
Minimum Observed Plasma Concentration During a Complete Dosing Interval (Cmin)
Day 1 of Cycle 1 (cycle length = 21 days)
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MSC2490484A 100 mg QDEXPERIMENTALParticipants received MSC2490484A capsules 100 milligram (mg) orally, once daily (QD) from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 200 mg QDEXPERIMENTALParticipants received MSC2490484A capsules 200 mg orally, QD from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 150 mg BIDEXPERIMENTALParticipants received MSC2490484A capsules 150 mg orally, twice daily (BID) from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 200 mg BIDEXPERIMENTALParticipants received MSC2490484A capsules 200 mg orally, BID from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 300 mg BIDEXPERIMENTALParticipants received MSC2490484A capsules 300 mg orally, BID from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 400 mg BIDEXPERIMENTALParticipants received MSC2490484A capsules 400 mg orally, BID from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
MSC2490484A 400 mg BID RP2DEXPERIMENTALParticipants received MSC2490484A capsules 400 mg recommended Phase II dose (RP2D) orally, BID from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.

Interventions

NameTypeDescription
MSC2490484A (M3814)DRUGParticipants received MSC2490484A capsules at escalated dose from 100 mg to 400 mg orally from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Advanced solid tumors likely to have alterations in DNA repair mechanisms, such as the BRCA and ATM pathways, or CLL, with no other standard surgical, radiation, or systemic anticancer therapies available. Subjects with CLL will be enrolled in 1 of the RP2D expansion cohorts o...

Countries:BelgiumDenmarkNetherlands
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about MSC2490484A

What is MSC2490484A used for?

MSC2490484A is an investigational small molecule being studied for the treatment of advanced solid tumors. It was evaluated in a Phase 1 clinical trial that also included patients with chronic lymphocytic leukemia. The drug is developed by Merck KGaA and is currently in clinical development, though the Phase 1 trial has been completed.

What does MSC2490484A target?

MSC2490484A is an inhibitor of a DNA-dependent protein kinase. This target is involved in DNA repair pathways, and inhibiting it is being explored as a potential approach in oncology. The drug is being developed by Merck KGaA for the treatment of advanced solid tumors.

Who makes MSC2490484A?

MSC2490484A is being developed by Merck KGaA, a science and technology company. The company's ticker symbol is MKGAF. The drug is an investigational small molecule being studied for advanced solid tumors, and it has completed a Phase 1 clinical trial.

What phase is MSC2490484A in?

MSC2490484A is in Phase 1 clinical development. The Phase 1 trial, NCT02316197, has been completed. The drug is investigational and not yet approved. It is being studied for the treatment of advanced solid tumors and chronic lymphocytic leukemia.

What clinical trials is MSC2490484A in?

MSC2490484A has been studied in one clinical trial, NCT02316197, titled "Clinical Phase I Study Investigating MSC2490484A, an Inhibitor of a DNA-dependent Protein Kinase, in Advanced Solid Tumors or Chronic Lymphocytic Leukemia." This Phase 1 trial enrolled 31 participants and was conducted in Belgium, Denmark, and the Netherlands. The trial has been completed.

Is MSC2490484A the same as any other drug?

MSC2490484A is the drug name used in clinical trials. No alternative names have been reported for this investigational agent. It is being developed by Merck KGaA for the treatment of advanced solid tumors and has completed a Phase 1 clinical trial.