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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| ClinicalTrials.gov Identifier: NCT02875223 |
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Recruitment Status :
Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : September 19, 2022
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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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 |
| 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
Drug Information available for:
Itraconazole
| 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 :
- Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]Number of participants with DLT
- Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria [ Time Frame: Up to approximately 28 days ]
- Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 9 years ]
- Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to approximately 9 years ]
- AUC from time zero to the last quantifiable concentration (AUC0-t) [ Time Frame: Up to approximately 9 years ]
Secondary Outcome Measures :
- 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)
- 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)
- 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
- 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
- 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
Locations
Show 28 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | September 19, 2022 |
| Last Verified: | September 2022 |
Keywords provided by Celgene:
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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 |