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INCB028060

Phase 1

Solid Tumor | Small molecule | Oncology |Incyte Corporation|Last Updated: Nov 22, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

INCB028060 · 1 trial · 3 indications

Phase 1 1
NCT01072266A Dose-escalation Study in Subjects With Advanced MalignanciesSolid Tumor
COMPLETED45 Analytics
PHASE1COMPLETED
A Dose-escalation Study in Subjects With Advanced Malignancies
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs
Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.

Secondary Endpoints

c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation
Predose, specific hours post-dose on day and Day 15 of Cycle 1.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB028060EXPERIMENTALSubjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.

Interventions

NameTypeDescription
INCB028060DRUG10 mg and 50 mg capsules will be provided and dosed per 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about INCB028060

What is INCB028060 used for?

INCB028060 is an investigational small molecule being studied for the treatment of solid tumors, including advanced and metastatic cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes INCB028060?

INCB028060 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY.

What phase is INCB028060 in?

INCB028060 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.

What clinical trials is INCB028060 in?

INCB028060 has been studied in a Phase 1 dose-escalation trial, NCT01072266, titled "A Dose-escalation Study in Subjects With Advanced Malignancies." The trial enrolled 45 participants with solid tumors, advanced cancer, or metastatic cancer in the United States and has been completed.

Is INCB028060 a small molecule?

Yes, INCB028060 is a small molecule therapeutic developed for oncology indications. It is being investigated as a potential treatment for solid tumors.