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A Study of ARRY-520 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00462358
First received: April 18, 2007
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.

This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).


Condition Intervention Phase
Advanced Solid Tumors
 Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Assess the efficacy of the study drug in terms of tumor response. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: April 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-520 Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Experimental: ARRY-520 + G-CSF support Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Part 1: standard of care; Part 2: standard of care.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462358

Locations
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University, Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00462358     History of Changes
Other Study ID Numbers: ARRAY-520-101
Study First Received: April 18, 2007
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013