A Dose-escalation Study in Subjects With Advanced Malignancies

NCT ID: NCT01195311

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-07-31

Brief Summary

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

Conditions

Solid Tumors and Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCB024360

Group Type: EXPERIMENTAL

INCB024360

Intervention Type: DRUG

INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

Interventions

INCB024360

INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lance Leopold, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Chicago, Illinois, United States

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

INCB 24360-101

Identifier Type: -

Identifier Source: org_study_id