A Dose-escalation Study in Subjects With Advanced Malignancies

Phase 1

Completed

• Conditions: Advanced Cancer; Metastatic Cancer; Solid Tumor
• Interventions: Drug: INCB028060

• Registration Number: NCT01072266
• Lead Sponsor: Incyte Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2012-07
• Study Completion: 2013-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INCB028060	INCB028060	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.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs	Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.

Secondary Outcome Measures

Name	Time	Method
c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation	Predose, specific hours post-dose on day and Day 15 of Cycle 1.	Samples will be collected at 0 (predose) and 2, 4, and 6 hours after dosing on Day 1 and Day 15 of Cycle 1 for subjects undergoing full PK analysis.