TerminatedPhase 1

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

Stopped: Business objectives have changed

France, Italy75 participantsStarted 2016-08-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists * Eastern Cooperative Oncology Group Performance Status of 0 to 1 Exclusion Criteria: * Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered * Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages * Impaired cardiac function or clinically significant cardiac diseases * Poor bone marrow reserve as assessed by Investigator Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined inclusion/exclusion criteria apply

What they're measuring

Part A - Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Each cycle is of 28 days)

Part A - Maximum Tolerated Dose (MTDs)

Timeframe: Cycle 1 (Each cycle is of 28 days)

Trial details

NCT IDNCT02875223

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-25

Results submitted2025-03-21