A Dose-escalation Study in Subjects With Advanced Malignancies

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Drug: INCB028060

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States
  • Tennessee
    • Nashville, Tennessee, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: INCB028060; 10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation	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.	Predose, specific hours post-dose on day and Day 15 of Cycle 1.

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Collaborators: Novartis Pharmaceuticals
• Investigators: Study Director: Lance Leopold, Incyte Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimate): February 22, 2010

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Refractory, Advanced malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: INCB 28060-101