Status:
COMPLETED
A Study of ARRY-334543 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 a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug ...
Eligibility Criteria
Inclusion
- Key
- Histological or cytological evidence of malignancy.
- Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Additional criteria exist.
- Key
Exclusion
- Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
- Use of an investigational medication or device within 30 days prior to first dose of study drug.
- Major surgery within 30 days prior to first dose of study drug.
- Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
- Additional criteria exist.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00637702
Start Date
February 1 2008
End Date
October 1 2012
Last Update
October 8 2020
Active Locations (2)
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1
Juravinski Cancer Center at Hamilton Heath Sciences
Hamilton, Ontario, Canada, L8V 5C2
2
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6