Study Completed

Advanced Cancer

Bayer Identifier:

15505

ClinicalTrials.gov Identifier:

NCT00610194

EudraCT Number:

Not Available

EU CT Number:

Not Available

Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients

Trial purpose

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 RDEA119 when given once orally on Day 1 of the study
• To describe the PK of different doses of RDEA119 when given orally as continuous dosing.
• To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers
• To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose
• To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort

Key Participants Requirements

Sex

Both

Age

18 Years

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 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.

Trial summary

Enrollment Goal

Trial Dates

November 2007 - August 2012

Phase

Phase 1

Could I Receive a placebo

Products

Refametinib (BAY86-9766)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	TGen Clinical Research Services at Scottsdale Healthcare	Scottsdale, 85258, United States
Completed	UCHSC	Aurora, 80045, United States
Completed	Roswell Park Cancer	Buffalo, 14263, United States

Primary Outcome

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
Time Frame:
35 Days
Safety Issue:
Yes

Secondary Outcome

Pharmacokinetics and Pharmacodynamics
Time Frame:
35 Days
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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