A Dose-escalation Study in Subjects With Advanced Malignancies

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072266
• Other study ID #: INCB 28060-101
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2010
• Last updated: November 20, 2017
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: November 2017
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Incyte Corporation	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.