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

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT02875223
• Collaborator: (none)
• Enrollment: 91
• Locations: 27
• Arms: 2
• Anticipated Duration (Months): 105.9
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0

Study Details

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

1. 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	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin; Neoplasms	Drug: CC-90011; Drug: Rifampicin; Drug: Itraconazole	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 91 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 31, 2016
• Anticipated Primary Completion Date: Aug 8, 2023
• Anticipated Study Completion Date: Jun 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CC-90011 and Rifampicin	Drug: CC-90011; Specified dose on specified days; Drug: Rifampicin; Specified dose on specified days
Experimental: CC-90011 and Itraconazole	Drug: CC-90011; Specified dose on specified days; Drug: Itraconazole; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Dose-Limiting Toxicity (DLT) [Up to approximately 28 days]

   Number of participants with DLT

2. Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria [Up to approximately 28 days]

3. Maximum observed plasma concentration (Cmax) [Up to approximately 9 years]

4. Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [Up to approximately 9 years]

5. AUC from time zero to the last quantifiable concentration (AUC0-t) [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 [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) [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) [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) [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) [Up to approximately 8 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Georges Francois Leclerc	Dijon		France	21079
2	Local Institution - 101	Dijon		France	21079
3	Institut Paoli Calmettes	Marseille Cedex 9		France	13273
4	Local Institution - 102	Marseille Cedex 9		France	13273
5	Gustave Roussy	Villejuif Cedex		France	94805
6	Local Institution - 100	Villejuif Cedex		France	94805
7	Bologna University	Bologna		Italy	40123
8	Local Institution - 200	Bologna		Italy	40123
9	Istituto Nazionale Dei Tumori	Milano		Italy	20133
10	Istituto Europeo di Oncologia	Milano		Italy	20141
11	Local Institution - 202	Milano		Italy	20141
12	Local Institution - 501	Chuo-ku	Tokyo	Japan	104-0045
13	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
14	The Cancer Institute Hospital of Japanese Foundation For Cancer Research	Koto-ku	Tokyo	Japan
15	Local Institution - 502	Koto	Tokyo	Japan	135-8550
16	Local Institution - 500	Kashiwa		Japan	277-8577
17	National Cancer Center Hospital East	Kashiwa		Japan	277-8577
18	Hospital Universitario Vall D hebron - PPDS	Barcelona		Spain	08035
19	Local Institution - 400	Barcelona		Spain	08035
20	Fundacion Jimenez Daaz	Madrid		Spain	28040
21	Local Institution - 402	Madrid		Spain	28040
22	Hospital 12 de Octubre	Madrid		Spain	28041
23	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008
24	Local Institution - 300	London		United Kingdom	SW3 6JJ
25	Royal Marsden Hospital	London		United Kingdom	SW3 6JJ
26	Freeman Hospital	Newcastle Upon Tyne		United Kingdom	NE7 7DN
27	Local Institution - 301	Newcastle Upon Tyne		United Kingdom	NE7 7DN

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

Publications

• 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: Aug 23, 2016
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 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; Itraconazole; Rifampin; Pulrodemstat besilate

Study Results

No Results Posted as of Jul 8, 2022