Status:
COMPLETED
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Lead Sponsor:
Bayer
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients. Secondary Objectives: * To describe the initial PK of different doses of ...
Eligibility Criteria
Inclusion
- Histological or cytological confirmed solid tumor. - Advanced metastatic or locally recurrent disease for which no proven effective therapy exists. - In the expanded MTD cohort, a minimum of 10 patients must have an accessible tumor that is amendable to biopsy (cut or needle) at the start and during the study. For patients not in the biopsy group, a block from the patient's original diagnostic biopsy/excision, if available, may be used for genotype analysis. - ECOG performance status of 0-1. - Life expectancy of \> or equal to 3 months. - Acceptable hematology, clinical chemistry, and coagulation laboratory values. - Patient must be acceptable for treatment and follow up according to the Investigator. - Patent must have agreed to and signed the Informed Consent. - Patient has within normal range cardiac function as measured by echocardiogram or MUGA scan.
Exclusion
- Use of investigational agents or devices within the last 28 days. - Major surgery within 30 days of start of study. - Patients with documented CNS metastasis who are not off steroids and other CNS therapies - Evidence of uncontrolled active infections. - Other serious medical or psychiatric illness. - Significant cardiac dysfunction including congestive heart failure (NYHA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormalities unless corrected with a cardiac pacemaker; prolonged QTc \>460msec. - Patients with known hypersensitivity to any of the drugs or components given in this protocol. - Pregnancy. - Women or men of childbearing potential not willing to use effective contraception, including barrier protection. - Patients with abdominal fistula, GI perforation, intra-abdominal abscess, or small bowel resection, any of which is within 6 months of study entry. - Patients with abdominal radiation resulting in chronic diarrhea. - Because RDEA119 is primarily metabolized by CYP3A4 and CYP2C19, inhibitors and inducers of these enzymes should be avoided. - Patients with known HIV infection will be excluded.
Key Trial Info
Start Date :
November 28 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00610194
Start Date
November 28 2007
End Date
August 1 2012
Last Update
October 18 2023
Active Locations (3)
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1
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
UCHSC
Aurora, Colorado, United States, 80045
3
Roswell Park Cancer
Buffalo, New York, United States, 14263