A Dose-escalation Study in Subjects With Advanced Malignancies

Incyte

Status and phase: Completed; Phase 1

Conditions: Metastatic Cancer; Advanced Cancer; Solid Tumor

Treatments: Drug: INCB028060

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072266

INCB 28060-101

Details and patient eligibility

About

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (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. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

INCB028060

Experimental group

Description:

Subjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.

Treatment:

Drug: INCB028060