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 investigational study drug ARRY-334543. This study has 2 parts. In the first part, patients will receive increasi...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Part 2):
- Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
- Measurable disease (at least 1 target lesion) according to modified RECIST.
- Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
- Additional criteria exist.
- Key Exclusion Criteria (Part 2):
- 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).
- 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).
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C.
- Additional criteria exist.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00278902
Start Date
January 1 2006
End Date
June 1 2009
Last Update
October 14 2020
Active Locations (5)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
2
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
4
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3