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A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignancies

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Trial Information

A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies


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.

Exclusion Criteria:

- Subjects who received any anti-cancer medications in the 21 days prior to receiving
their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.

- Subjects with history of brain metastases or spinal cord compression.

- Subjects who have undergone a bone marrow or solid organ transplant.

- Subjects who have had major surgery within 4 weeks prior to study entry or had minor
surgical procedure within 7 days prior to initiating treatment.

- Subjects with a history of any gastrointestinal condition

- Is receiving any compound that is known to be a potent inducer or inhibitor of CYP3A4

- Subjects with an active autoimmune process or is receiving therapy for an autoimmune
disease

- Subjects treated with a serotonin reuptake inhibitor within 3 weeks prior to study
entry

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as measured by adverse events and dose limiting toxicities

Outcome Time Frame:

Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)

Safety Issue:

Yes

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation

Authority:

United States: Food and Drug Administration

Study ID:

INCB 24360-101

NCT ID:

NCT01195311

Start Date:

July 2010

Completion Date:

May 2013

Related Keywords:

  • Advanced Malignancies
  • Refractory, Advanced malignancies
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Philadelphia, Pennsylvania  19104