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INCB024360

Phase 1

Solid Tumors and Hematologic Malignancy | Small molecule | Oncology |Incyte Corporation|Last Updated: Jan 17, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

INCB024360 · 1 trial · 1 indication

Phase 1 1
NCT01195311A Dose-escalation Study in Subjects With Advanced MalignanciesSolid Tumors and Hematologic Malignancy
COMPLETED52 Analytics
PHASE1COMPLETED
A Dose-escalation Study in Subjects With Advanced Malignancies
Solid Tumors and Hematologic Malignancy
NCT0119531152
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Study Endpoints

Primary Endpoints

Safety and tolerability as measured by adverse events and dose limiting toxicities
Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)

Secondary Endpoints

Tumor assessment as measured by RECIST criteria
Measured from baseline through treatment cessation. (Measured every other cycle and end of study)
Measurement of IDO inhibition in whole blood measured through blood sampling.
Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1
PK analysis
Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB024360EXPERIMENTAL -

Interventions

NameTypeDescription
INCB024360DRUGINCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available * Subjects with life expectancy of 12 weeks or longer. * Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Excl...

Countries:United States
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Frequently asked questions about INCB024360

What is INCB024360 used for?

INCB024360 is an investigational small molecule being studied for the treatment of solid tumors and hematologic malignancies. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is intended for patients with advanced malignancies, as studied in a dose-escalation trial.

What does INCB024360 target?

INCB024360 is a small molecule developed by Incyte Corporation. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in oncology, specifically for solid tumors and hematologic malignancies.

Who makes INCB024360?

INCB024360 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical research on this investigational drug for the treatment of advanced malignancies.

What phase is INCB024360 in?

INCB024360 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The drug is being studied for safety and dosing in patients with solid tumors and hematologic malignancies.

What clinical trials is INCB024360 in?

INCB024360 has one completed clinical trial, NCT01195311, titled 'A Dose-escalation Study in Subjects With Advanced Malignancies.' This Phase 1 study enrolled 52 participants in the United States and evaluated the drug in patients with solid tumors and hematologic malignancies.