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A Dose-escalation Study in Subjects With Advanced Malignancies

NCT ID: NCT01072266

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Solid Tumor Advanced Cancer Metastatic Cancer

Keywords

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Refractory, Advanced malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

INCB028060

Intervention Type DRUG

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

Interventions

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INCB028060

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lance Leopold

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Baltimore, Maryland, United States

Site Status

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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INCB 28060-101

Identifier Type: -

Identifier Source: org_study_id