Status:
COMPLETED
A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Advanced Solid Tumors
Advanced or Metastatic Biliary 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-438162 (MEK162). This study has 3 parts. In the first part, patients with advance...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (for Part 3):
- A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma which is metastatic (measurable disease).
- Documented KRAS- or BRAF- tumor mutation.
- Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU), oxaliplatin, irinotecan and, if available, bevacizumab.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Additional criteria exist.
- Key Exclusion Criteria (for Part 3):
- Uncontrolled or symptomatic brain metastases (if the patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
- History of central serous retinopathy, retinopathy visible at baseline that would be considered a risk factor for central serous retinopathy or retinal vein occlusion.
- Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stage A low grade prostate cancer may enroll irrespective of the time of diagnosis.
- Prior treatment with a MEK inhibitor.
- Treatment with prior chemotherapy, anticancer immunotherapy, monoclonal antibodies or other protein or peptide therapeutics within 21 days of the first dose of study drug.
- Treatment with a small molecule targeted agent or anticancer hormonal therapy within 14 days of the first dose of study drug.
- Treatment with prior radiotherapy within 28 days of initiating study drug (if the radiation portal covered ≤ 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
- Major surgery within 4 weeks or minor surgery within 7 days prior to the first dose of study drug.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
- Additional criteria exist.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00959127
Start Date
August 1 2009
End Date
January 1 2013
Last Update
September 16 2020
Active Locations (10)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
3
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-1000
4
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02114