Status:
TERMINATED
Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors
Lead Sponsor:
Celgene
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 m...
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 li...
Eligibility Criteria
Inclusion
- Eligible study subjects in Part 1 and Part 2 must be 18 years or older
- Eligible study subjects must have histologic or cytologic confirmation of advanced, unresectable or metastatic solid tumors, and have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac functions as assessed by laboratory tests, ECG and ECHO or MUGA scan.
Exclusion
- Subjects with symptomatic or unstable CNS metastases
- Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy
- Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study
Key Trial Info
Start Date :
January 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02313012
Start Date
January 5 2015
End Date
May 3 2016
Last Update
November 18 2019
Active Locations (5)
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1
Cedars Sinai Medical Center, Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
2
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
3
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
4
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203