A Study of ARRY-520 in Patients With Advanced Cancer

Advanced Solid Tumors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462358
• Other study ID #: ARRAY-520-101
• Status: Completed
• Phase: Phase 1
• Start date: April 2007
• Est. completion date: November 2010

Study information

• Verified date: September 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
• Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Part 1: standard of care; Part 2: standard of care.

Locations

Country	Name	City	State
United States	Marlene and Stewart Greenebaum Cancer Center	Baltimore	Maryland
United States	Wayne State University, Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.		Part 1
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1 and Part 2
Secondary	Characterize the pharmacokinetics of the study drug.		Part 1 and Part 2
Secondary	Assess the efficacy of the study drug in terms of tumor response.		Part 1 and Part 2