Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Advanced Malignancies
Drug: INCB024360
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB024360 Drug: INCB024360
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195311

Locations
United States, Illinois
Chicago, Illinois, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Lance Leopold, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01195311     History of Changes
Other Study ID Numbers: INCB 24360-101
Study First Received: August 18, 2010
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Refractory, Advanced malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014