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A Dose-escalation Study in Subjects With Advanced Malignancies

Primary Purpose

Solid Tumors and Hematologic Malignancy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

INCB024360

About this trial

This is an interventional treatment trial for Solid Tumors and Hematologic Malignancy focused on measuring Refractory, Advanced malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INCB024360

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tumor assessment as measured by RECIST criteria

Measurement of IDO inhibition in whole blood measured through blood sampling.

PK analysis

Full Information

NCT ID

NCT01195311

First Posted

August 18, 2010

Last Updated

January 15, 2018

Sponsor

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01195311

Brief Title

A Dose-escalation Study in Subjects With Advanced Malignancies

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Incyte Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumors and Hematologic Malignancy

Keywords

Refractory, Advanced malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INCB024360

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

INCB024360

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Tumor assessment as measured by RECIST criteria

Time Frame

Measured from baseline through treatment cessation. (Measured every other cycle and end of study)

Title

Measurement of IDO inhibition in whole blood measured through blood sampling.

Time Frame

Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1

Title

PK analysis

Time Frame

Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lance Leopold, MD

Organizational Affiliation

Incyte Corporation

Official's Role

Study Director

Facility Information:

City

Chicago

State/Province

Illinois

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Dose-escalation Study in Subjects With Advanced Malignancies

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