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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

Tracking Information
First Submitted Date  ICMJE August 18, 2010
First Posted Date  ICMJE September 6, 2010
Last Update Posted Date January 17, 2018
Study Start Date  ICMJE July 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
Safety/tolerability; assessed by monitoring frequency, duration & severity of AEs and from changes in clinical lab findings, vital signs & ECGs. Subjects monitored for evidence of unexpected immune activity [ Time Frame: 18-24 months following initiation of study drug ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • Tumor assessment as measured by RECIST criteria [ Time Frame: 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. [ Time Frame: Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
Secondary endpoints include the assessment of tumor response rates and IDO inhibitory activity using pharmacodynamic & pharmacokinetic methods. [ Time Frame: 18-24 months following initiation of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-escalation Study in Subjects With Advanced Malignancies
Official Title  ICMJE A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors and Hematologic Malignancy
Intervention  ICMJE Drug: INCB024360
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
Study Arms  ICMJE Experimental: INCB024360
Intervention: Drug: INCB024360
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2010)
50
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01195311
Other Study ID Numbers  ICMJE INCB 24360-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Incyte Corporation
Original Responsible Party Pam Murphy, Investor Relations and Corporate Management, Incyte Corporation
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lance Leopold, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP