A Dose-escalation Study in Subjects With Advanced Malignancies

NCT01195311 | Completed Phase 1

• 1 other identifier: INCB 24360-101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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

Keywords

Refractory, Advanced malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

INCB024360

EXPERIMENTAL

Drug: INCB024360

Interventions

INCB024360 DRUG

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

INCB024360

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (2)

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

epacadostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lance Leopold, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: September 6, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (2)