Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors

• Status: Terminated
• Trial end date: 2016-05-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

Inclusion Criteria:

1. Eligible study subjects in Part 1 and Part 2 must be 18 years or older

2. 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

3. Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

4. 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 Criteria:

1. Subjects with symptomatic or unstable CNS metastases

2. Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy

3. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study