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

NCT02875223 | Terminated Phase 1 Results

• 1 other identifier: CC-90011-ST-001
• Study Type: interventional
• Target: 75
• Locations: 5 countries
• Sites: 15

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.

Conditions

Lymphoma, Non-Hodgkin; Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia \> 7 days, Grade 4 thrombocytopenia \> 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.

  Cycle 1 (Each cycle is of 28 days)

• Part A - Maximum Tolerated Dose (MTDs)

  The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia \> 7 days, Grade 4 thrombocytopenia \> 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.

  Cycle 1 (Each cycle is of 28 days)

Secondary Outcomes (16)

• Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)

  From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)

• Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)

  From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)

• Part A - Duration of Response (DoR) Based on Confirmed Responses

  From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)

• Part A - Progression-Free Survival (PFS)

  From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)

• Part A - Overall Survival (OS)

  From first dose (Day 1) until death due to any cause (up to 803 days)

Study Arms (2)

CC-90011 and Rifampicin

EXPERIMENTAL

Drug: CC-90011; Drug: Rifampicin

CC-90011 and Itraconazole

EXPERIMENTAL

Drug: CC-90011; Drug: Itraconazole

Interventions

CC-90011 DRUG

Specified dose on specified days

CC-90011 and Itraconazole; CC-90011 and Rifampicin

Rifampicin DRUG

Specified dose on specified days

CC-90011 and Rifampicin

Itraconazole DRUG

Specified dose on specified days

CC-90011 and Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (15)

Local Institution - 101

Dijon, 21079, France

Location

Local Institution - 102

Marseille, 13273, France

Location

Local Institution - 100

Villejuif, 94805, France

Location

Local Institution - 200

Bologna, 40123, Italy

Location

Local Institution - 201

Milan, 20133, Italy

Location

Local Institution - 202

Milan, 20141, Italy

Location

Local Institution - 501

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 502

Koto-Ku, Tokyo, 135-8550, Japan

Location

Local Institution - 500

Kashiwa, 277-8577, Japan

Location

Local Institution - 400

Barcelona, 08035, Spain

Location

Local Institution - 402

Madrid, 28040, Spain

Location

Local Institution - 404

Madrid, 28041, Spain

Location

Local Institution - 401

Santander, 39008, Spain

Location

Local Institution - 300

London, SW3 6JJ, United Kingdom

Location

Local Institution - 301

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33046517 BACKGROUND

• Hollebecque A, Salvagni S, Plummer R, Niccoli P, Capdevila J, Curigliano G, Moreno V, de Braud F, de Villambrosia SG, Martin-Romano P, Baudin E, Arias M, de Alvaro J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Clinical activity of CC-90011, an oral, potent, and reversible LSD1 inhibitor, in advanced malignancies. Cancer. 2022 Sep 1;128(17):3185-3195. doi: 10.1002/cncr.34366. Epub 2022 Jun 23.

  PMID: 35737639 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Neoplasms

Interventions

pulrodemstat besilate; Rifampin; Itraconazole

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: August 31, 2016
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

JP (3); ES (4); GB (2); FR (3); IT (3)