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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02875223
• Other study ID #: CC-90011-ST-001
• Status: Terminated
• Phase: Phase 1
• Start date: August 31, 2016
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Neoplasms

Intervention

Drug:
• CC-90011
Specified dose on specified days
• Rifampicin
Specified dose on specified days
• Itraconazole
Specified dose on specified days

Locations

Country	Name	City	State
France	Local Institution - 101	Dijon
France	Local Institution - 102	Marseille Cedex 9
France	Local Institution - 100	Villejuif Cedex
Italy	Local Institution - 200	Bologna
Italy	Local Institution - 201	Milano
Italy	Local Institution - 202	Milano
Japan	Local Institution - 501	Chuo-ku	Tokyo
Japan	Local Institution - 500	Kashiwa
Japan	Local Institution - 502	Koto-Ku	Tokyo
Spain	Local Institution - 400	Barcelona
Spain	Local Institution - 402	Madrid
Spain	Local Institution - 404	Madrid
Spain	Local Institution - 401	Santander
United Kingdom	Local Institution - 300	London
United Kingdom	Local Institution - 301	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

France,  Italy,  Japan,  Spain,  United Kingdom, 

References & Publications (1)

Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Phase I Study of Lysine-Specific Demethylase 1 Inhibitor, CC-90011, in Patients with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jan 15;27(2):438-446. doi: 10.1158/1078-0432.CCR-20-2380. Epub 2020 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity (DLT)	Number of participants with DLT	Up to approximately 28 days
Primary	Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria		Up to approximately 28 days
Primary	Maximum observed plasma concentration (Cmax)		Up to approximately 9 years
Primary	Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-8)		Up to approximately 9 years
Primary	AUC from time zero to the last quantifiable concentration (AUC0-t)		Up to approximately 9 years
Secondary	Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria	Is defined as tumor responses (as assessed by the Investigators) of complete response (CR), partial response (PR) and durable stable disease (SD) (SD of = 4 months duration)	Up to approximately 8 years
Secondary	Objective Response Rate (ORR)	Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR)	Up to approximately 8 years
Secondary	Progression-Free Survival (PFS)	Is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause	Up to approximately 8 years
Secondary	Overall Survival (OS)	Is measured as the time from the first dose of CC-90011 to death due to any cause	Up to approximately 8 years
Secondary	Duration of Response (DOR)		Up to approximately 8 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting