Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02313012
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2014-12-05
Brief Title:
Safety and PK Study of CC-90003 in RelapsedRefractory Solid Tumors
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1a Multicenter Open-label Safety Tolerability and Pharmacokinetic Study of CC-90003 a Selective Extracellular Signal-Regulated Kinase ERK Inhibitor in Subjects With Locally-Advanced or Metastatic Relapsed or Refractory BRAF or RAS-Mutated Malignancies
Status:
TERMINATED
Status Verified Date:
2019-11
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:
The CC-90003-ST -001 trial is a first-in-man open-label study in subjects with locally-advanced or wide spread cancers to determine if CC-90003 an oral medication can be adequately tolerated with minimal side effects
Detailed Description:
CC-90003-ST -001 is an open-label multicenter Phase 1a study in subjects with locally-advanced or metastatic solid tumors who are intolerant of resistant to or have relapsed after at least one line of therapy and for whom no standard therapy exists The study will be conducted in two parts Dose Escalation Part 1 and Cohort Expansion Part 2 Subjects may continue CC-90003 until progression of their underlying malignancy the occurrence of intolerable toxicity or physiciansubject decision to discontinue CC-90003 In Part 1 cohorts of subjects with relapsed or refractory solid tumors will receive increasing doses of CC-90003 in order to assess its safety and tolerability the maximum tolerated dose MTD and PK profile In Part 2 cohorts of subjects with specific tumors that harbor mutations involving the Mitogen -Activated Protein Kinase MAPK pathway will receive CC-90003 at or below the MTD until progression of disease intolerable toxicity or physiciansubject decision to discontinue CC-90003
Study Oversight
Has Oversight DMC:
None
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?:
None