A Dose-escalation Study in Subjects With Advanced Malignancies

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01072266
First received: February 18, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Advanced Malignancies
Drug: INCB028060
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs [ Time Frame: Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation [ Time Frame: Predose, specific hours post-dose on day and Day 15 of Cycle 1. ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072266

Locations
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
Incyte Corporation
Novartis Pharmaceuticals
Investigators
Study Director: Lance Leopold Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01072266     History of Changes
Other Study ID Numbers: INCB 28060-101
Study First Received: February 18, 2010
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Refractory, Advanced malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014