NCT00610194

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

January 2, 2008

Last Update Submit

October 16, 2023

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    35 Days

Secondary Outcomes (1)

  • Pharmacokinetics and Pharmacodynamics

    35 Days

Study Arms (1)

Arm 1

EXPERIMENTAL

In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.

Drug: RDEA119

Interventions

RDEA119DRUG

In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

UCHSC

Aurora, Colorado, 80045, United States

Location

Roswell Park Cancer

Buffalo, New York, 14263, United States

Location

Related Publications (1)

  • Weekes CD, Von Hoff DD, Adjei AA, Leffingwell DP, Eckhardt SG, Gore L, Lewis KD, Weiss GJ, Ramanathan RK, Dy GK, Ma WW, Sheedy B, Iverson C, Miner JN, Shen Z, Yeh LT, Dubowy RL, Jeffers M, Rajagopalan P, Clendeninn NJ. Multicenter phase I trial of the mitogen-activated protein kinase 1/2 inhibitor BAY 86-9766 in patients with advanced cancer. Clin Cancer Res. 2013 Mar 1;19(5):1232-43. doi: 10.1158/1078-0432.CCR-12-3529. Epub 2013 Feb 22.

    PMID: 23434733RESULT

MeSH Terms

Interventions

N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

February 7, 2008

Study Start

November 28, 2007

Primary Completion

November 24, 2010

Study Completion

August 1, 2012

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

US(3)