Status:
COMPLETED
A Study of ARRY-334543 and Docetaxel 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/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patient...
Eligibility Criteria
Inclusion
- Key
- Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
- Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Must be able to take and retain oral medications.
- Other criteria exist.
- Key
Exclusion
- Active concomitant malignancies.
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- Requiring intravenous (IV) alimentation.
- Pregnancy or lactation.
- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
- History of hypersensitivity to or intolerance of docetaxel.
- Other criteria exist.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00833326
Start Date
January 1 2009
End Date
July 1 2010
Last Update
October 6 2020
Active Locations (3)
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1
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
2
Mayo Cancer Center
Rochester, Minnesota, United States, 55905
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203