Status:
COMPLETED
A Study of ARRY-142886 in Patients With Advanced Cancer
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886. This study has 2 parts. In the first part, patients will receive increasi...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Part 2):
- Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Estimated life expectancy of greater than or equal to 3 months.
- Patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.
- Additional criteria exist.
- Key Exclusion Criteria (Part 2):
- Uncontrolled or symptomatic brain metastases.
- Use of investigational drug or device within 30 days prior to first dose of study drug.
- Major surgery within 30 days prior to study start.
- Radiotherapy or chemotherapy within 21 days prior to study start (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- Additional criteria exist.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00085787
Start Date
June 1 2004
End Date
February 1 2007
Last Update
October 14 2020
Active Locations (3)
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1
University of Colorado Cancer Center, Anschutz Cancer Center
Aurora, Colorado, United States, 80010
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111