Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT00610194
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2008-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of RDEA119, A MEK Inhibitor, in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RDEA119-101 | OTHER | Ardea | View |