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INCB007839

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

RandomizedCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

INCB007839 · 1 trial · 1 indication

Phase 1 1
NCT00820560Open-Label Study to Assess the Safety/Tolerability in Patients With Solid TumorsSolid Tumors and Hematologic Malignancy
COMPLETED41 Analytics
PHASE1COMPLETED
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
Solid Tumors and Hematologic MalignancyUnlock trial analytics

Study Endpoints

Primary Endpoints

Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Baseline through study completion

Secondary Endpoints

Evaluation of response rates as measured by RECIST criteria
At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response
Baseline and every visit through study termination
Evaluation of PD markers for HER2 and ErbB ligand levels
Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB07839 100mg, immediate release (IR) capsulesEXPERIMENTAL -
INCB07839 200 mg IR capsulesEXPERIMENTAL -

Interventions

NameTypeDescription
INCB007839DRUGINCB007839 100 or 200 mg/dose as IR capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of...

Countries:United States
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Frequently asked questions about INCB007839

What is INCB007839 used for?

INCB007839 is an investigational small molecule being studied for the treatment of solid tumors and hematologic malignancy. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes INCB007839?

INCB007839 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY.

What phase is INCB007839 in?

INCB007839 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is INCB007839 in?

INCB007839 has one completed clinical trial, NCT00820560, an open-label study to assess safety and tolerability in patients with solid tumors. The trial enrolled 41 participants in the United States and included patients aged 18 years and older.

Is INCB007839 FDA approved?

INCB007839 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not been authorized for marketing.