NCT02875223

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

A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL \[EMZL\], splenic MZL \[SMZL\], nodal MZL \[NMZL\], and histologic transformation of MZL). 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. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

Conditions

• Lymphoma, Non-Hodgkin
• Neoplasms

Interventions

Type	Name	Description
DRUG	CC-90011	Specified dose on specified days
DRUG	Rifampicin	Specified dose on specified days
DRUG	Itraconazole	Specified dose on specified days

Timeline

• Start date: 2016-08-31
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2016-08-23
• Last updated: 2025-04-20
• Results posted: 2025-04-20

Locations

15 sites across 5 countries: France, Italy, Japan, Spain, United Kingdom