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A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies

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Trial Information

A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies


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 clinically significant non-healing or healing wounds or subjects with
lung tumor lesions with increased likelihood of bleeding

- Subjects with a history of any gastrointestinal condition

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs

Outcome Time Frame:

Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.

Safety Issue:

Yes

Principal Investigator

Lance Leopold

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation

Authority:

United States: Food and Drug Administration

Study ID:

INCB 28060-101

NCT ID:

NCT01072266

Start Date:

January 2010

Completion Date:

January 2013

Related Keywords:

  • Advanced Malignancies
  • Refractory, Advanced malignancies
  • Neoplasms

Name

Location

Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Baltimore, Maryland  21287