A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT02875223 Recruiting August 23, 2016 May 27, 2022

study description
Brief 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.

Condition or Disease: Lymphoma, Non-Hodgkin
Neoplasms
Intervention/treatment: Drug: CC-90011
Drug: Rifampicin
Drug: Itraconazole
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 91 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
Actual Study Start Date: August 2016
Estimated Primary Completion Date: August 2023
Estimated Study Completion Date: June 2025

Arms and interventions
Arm Intervention/treatment
Experimental: CC-90011 and Itraconazole
Drug: CC-90011
Specified dose on specified days

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

Drug: Rifampicin
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]
Number of participants with DLT
2. Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria [ Time Frame: Up to approximately 28 days ]
3. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 9 years ]
4. Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to approximately 9 years ]
5. AUC from time zero to the last quantifiable concentration (AUC0-t) [ Time Frame: Up to approximately 9 years ]
Secondary Outcome Measures: 1. Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria [ Time Frame: Up to approximately 8 years ]
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)
2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 8 years ]
Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR)
3. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 8 years ]
Is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause
4. Overall Survival (OS) [ Time Frame: Up to approximately 8 years ]
Is measured as the time from the first dose of CC-90011 to death due to any cause
5. Duration of Response (DOR) [ Time Frame: Up to approximately 8 years ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations
France Centre Georges Francois Leclerc Dijon
France Institut Paoli Calmettes Marseille Cedex 9
France Gustave Roussy Villejuif Cedex
Italy Bologna University Bologna
Italy Istituto Nazionale Dei Tumori Milano
Italy Istituto Europeo di Oncologia Milano
Japan, Tokyo Local Institution - 501 Chuo-ku
Japan, Tokyo National Cancer Center Hospital Chuo-ku
Japan, Tokyo The Cancer Institute Hospital of Japanese Foundation For Cancer Research Koto-ku
Japan, Tokyo Local Institution - 502 Koto
Japan Local Institution - 500 Kashiwa
Japan National Cancer Center Hospital East Kashiwa
Spain Hospital Universitario Vall D hebron - PPDS Barcelona
Spain Fundacion Jimenez Daaz Madrid
Spain Hospital 12 de Octubre Madrid
Spain Hospital Universitario Marques de Valdecilla Santander
United Kingdom Local Institution - 300 London
United Kingdom Royal Marsden Hospital London
United Kingdom Freeman Hospital Newcastle Upon Tyne
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information

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, Sánchez-Pérez 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.

Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT02875223     
Other Study ID Numbers : CC-90011-ST-001
First Posted : August 23, 2016
Last Update Posted : May 27, 2022
Last Verified : May 2022
Keywords provided by Celgene: Safety
CC-90011
Advanced unresectable solid Tumors
Low intermediate-grade lung neuroendocrine tumors (Typical and Atypical carcinoids)
Neuroendocrine prostate cancer (NEPC)
R/R Non-Hodgkin's Lymphomas
Additional relevant MeSH terms :
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases