Status:
COMPLETED
A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will ...
Eligibility Criteria
Inclusion
- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
- Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
- At least one measurable or non-measurable lesion
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Exclusion
- Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
- Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01469130
Start Date
November 1 2011
End Date
February 1 2018
Last Update
October 5 2020
Active Locations (2)
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1
Pfizer Investigative Site
Nagoya, Aichi-ken, Japan, 466-8560
2
Pfizer Investigative Site
Yufu, Oita Prefecture, Japan, 879-5593