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A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of RDEA119, A MEK Inhibitor, in Advanced Cancer Patients

Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of RDEA119, A MEK Inhibitor, in Advanced Cancer Patients

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be assessed as adverse and drug related events, clinical laboratory test results (hematology, chemistry, coagulation, and urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination

Outcome Time Frame:

35 Days

Safety Issue:


Principal Investigator

Neil Clendeninn, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Ardea Biosciences


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

September 2012

Related Keywords:

  • Advanced Cancer
  • Neoplasms



TGen Clinical Research Services at Scottsdale Healthcare Scottsdale, Arizona  85258
UCHSC Aurora, Colorado  80045
Roswell Park Cancer Buffalo, New York  14263