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A Dose-escalation Study in Subjects With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01195311
First received: August 18, 2010
Last updated: February 10, 2014
Last verified: February 2014

August 18, 2010
February 10, 2014
July 2010
May 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01195311 on ClinicalTrials.gov Archive Site
  • Tumor assessment as measured by RECIST criteria [ Time Frame: Measured from baseline through treatment cessation. (Measured every other cycle and end of study) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Dose-escalation Study in Subjects With Advanced Malignancies
A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Malignancies
Drug: INCB024360
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
Experimental: INCB024360
Intervention: Drug: INCB024360
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01195311
INCB 24360-101
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Lance Leopold, MD Incyte Corporation
Incyte Corporation
February 2014

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