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

Celgene

Status and phase: Terminated; Phase 1

Conditions: Neoplasms; Lymphoma, Non-Hodgkin

Treatments: Drug: Itraconazole; Drug: CC-90011; Drug: Rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02875223

CC-90011-ST-001

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

CC-90011 and Rifampicin

Experimental group

Treatment:

Drug: CC-90011

Drug: Rifampicin

CC-90011 and Itraconazole

Experimental group

Treatment:

Drug: CC-90011

Drug: Itraconazole