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NCT Number: NCT01195311

A Dose-escalation Study in Subjects 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.

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Key information

Conditions

Solid Tumors and Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCB024360

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2010
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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