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

Primary Purpose

Lymphoma, Non-Hodgkin, Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-90011
Rifampicin
Itraconazole
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Local Institution - 101
  • Local Institution - 102
  • Local Institution - 100
  • Local Institution - 200
  • Local Institution - 201
  • Local Institution - 202
  • Local Institution - 501
  • Local Institution - 502
  • Local Institution - 500
  • Local Institution - 400
  • Local Institution - 402
  • Local Institution - 404
  • Local Institution - 401
  • Local Institution - 300
  • Local Institution - 301

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CC-90011 and Rifampicin

CC-90011 and Itraconazole

Arm Description

Outcomes

Primary Outcome Measures

Dose-Limiting Toxicity (DLT)
Number of participants with DLT
Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
AUC from time zero to the last quantifiable concentration (AUC0-t)

Secondary Outcome Measures

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)
Objective Response Rate (ORR)
Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR)
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
Overall Survival (OS)
Is measured as the time from the first dose of CC-90011 to death due to any cause
Duration of Response (DOR)

Full Information

First Posted
August 18, 2016
Last Updated
July 24, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02875223
Brief Title
A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
August 8, 2023 (Anticipated)
Study Completion Date
June 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 101
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution - 102
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 100
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 200
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Local Institution - 201
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 202
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution - 501
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution - 502
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution - 500
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Local Institution - 400
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 402
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 404
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 401
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 300
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution - 301
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33046517
Citation
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.
Results Reference
background
PubMed Identifier
35737639
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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

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