A Dose-escalation Study in Subjects With Advanced Malignancies

NCT01072266 | Completed Phase 1

• 1 other identifier: INCB 28060-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor; Advanced Cancer; Metastatic Cancer

Keywords

Refractory, Advanced malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

INCB028060

EXPERIMENTAL

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

Interventions

INCB028060 DRUG

10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.

INCB028060

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lance Leopold

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

US (2)