Last updated on December 2018

A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Brief description of study

Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with relapsed and/or refractory solid tumors (including neuroendocrine carcinomas (NEC)) and Non-Hodgkin's lymphomas (NHLs). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011.

Detailed Study Description

Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days ( 3 days) prior to first dose of CC-90011. The informed consent document (ICD) must be signed and dated by the subject and the administering staff prior to the start of any other study procedures. All screening tests and procedures must be completed within the 28 days (3 days) prior to the first dose of CC-90011.

Treatment Period During the Treatment Period, CC-90011 will initially be administered orally in each 4-week (28 day) Cycle.

Follow-up Period In the Follow-up Period, subjects will be followed for 28 days ( 3 days) after the last dose of CC-90011 for safety.

After the Safety Follow-up visit, all subjects will be followed every subsequent 3 months ( 2 weeks) for survival follow-up for up until 2 years or until death, lost to follow-up, or the End of Trial, whichever occurs first.

Clinical Study Identifier: NCT02875223

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