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Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information


Key

Inclusion Criteria:



- Histological or cytological evidence of malignancy.

- Advanced solid tumors that have recurred or progressed following standard
therapy(ies).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

- Adequate hematology counts and serum chemistry values.

- Additional criteria exist.

Key Exclusion Criteria:

- Treatment with an investigational product or device, or anti-neoplastic therapy (with
the exclusion of hormone therapy where the therapy will continue at a standard dose
throughout the study) within 28 days prior to the first dose of study drug.

- Major surgery within 28 days prior to the first dose of study drug.

- Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if
local RT to <5% of the bone marrow).

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C,
and/or active hepatitis B.

- Additional criteria exist.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

Outcome Time Frame:

Part 1

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-520-101

NCT ID:

NCT00462358

Start Date:

April 2007

Completion Date:

November 2010

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Wayne State University, Karmanos Cancer Institute Detroit, Michigan  
Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland  21201