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A Dose-escalation Study in Subjects With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01195311
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.


Condition or disease Intervention/treatment Phase
Solid Tumors and Hematologic Malignancy Drug: INCB024360 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: INCB024360 Drug: INCB024360
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Tumor assessment as measured by RECIST criteria [ Time Frame: Measured from baseline through treatment cessation. (Measured every other cycle and end of study) ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195311


Locations
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United States, Illinois
Chicago, Illinois, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Lance Leopold, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01195311    
Other Study ID Numbers: INCB 24360-101
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Keywords provided by Incyte Corporation:
Refractory, Advanced malignancies
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases