Status:
COMPLETED
A Study of ARRY-334543 and Capecitabine 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 capecitabine. Patients will receive increasing doses of stud...
Eligibility Criteria
Inclusion
- Key
- Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Must be able to take and retain oral medications.
- Additional 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).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Requiring intravenous (IV) alimentation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- Pregnancy or lactation.
- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
- History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
- Additional criteria exist.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00710736
Start Date
June 1 2008
End Date
April 1 2011
Last Update
October 6 2020
Active Locations (4)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6