Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors
Stopped early · Phase 1
Conditions studied: Neoplasm Metastasis
In brief
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.
Key facts
- Study ID
- NCT02313012
- Run by
- Celgene
- People needed
- 19
- Starts
- 2015-01-05
- Expected to finish
- 2016-05-03
- Last updated by the study team
- 2019-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cedars Sinai Medical Center, Inflammatory Bowel Disease Center — Los Angeles, California, United States
- Smilow Cancer Center — New Haven, Connecticut, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States
- Peter MacCallum Cancer Centre — Melbourne, Australia
Full record on ClinicalTrials.gov
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