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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02875223
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 31, 2016
Estimated Primary Completion Date : August 8, 2023
Estimated Study Completion Date : June 29, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




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 ]


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875223


Contacts
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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
Show Show 19 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02875223    
Other Study ID Numbers: CC-90011-ST-001
First Posted: August 23, 2016    Key Record Dates
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:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Itraconazole
Rifampin
Pulrodemstat besilate
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers