Trial Information
An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced and/or metastatic cancer not amenable to standard therapy;
- any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small
cell lung cancer (Part 2);
- measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);
- ECOG performance status 0-1.
Exclusion Criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of
study drug;
- prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study
drug;
- known past or present CNS metastases;
- acute or chronic infection.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (Part 1)
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO21895
NCT ID:
NCT00773526
Start Date:
November 2008
Completion Date:
August 2012
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