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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 |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT02875223 | Recruiting | August 23, 2016 | May 27, 2022 |
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| study description |
| Brief Summary |
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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: |
Lymphoma, Non-Hodgkin Neoplasms |
| Intervention/treatment: |
Drug: CC-90011 Drug: Rifampicin Drug: Itraconazole |
| Phase: | Phase 1 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: CC-90011 and Itraconazole |
Drug: CC-90011 Specified dose on specified days Drug: Itraconazole Specified dose on specified days |
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Experimental: CC-90011 and Rifampicin |
Drug: CC-90011 Specified dose on specified days Drug: Rifampicin Specified dose on specified days |
| outcome measures |
| Primary Outcome Measures: |
1. Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ] Number of participants with DLT |
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2. Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria [ Time Frame: Up to approximately 28 days ] |
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3. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 9 years ] |
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4. Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to approximately 9 years ] |
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5. AUC from time zero to the last quantifiable concentration (AUC0-t) [ Time Frame: Up to approximately 9 years ] |
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| 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) |
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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) |
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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 |
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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 |
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5. Duration of Response (DOR) [ Time Frame: Up to approximately 8 years ] |
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| Eligibility Criteria |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Criteria |
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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 |
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| Contacts and Locations |
| 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 |
| France | Centre Georges Francois Leclerc | Dijon |
| France | Institut Paoli Calmettes | Marseille Cedex 9 |
| France | Gustave Roussy | Villejuif Cedex |
| Italy | Bologna University | Bologna |
| Italy | Istituto Nazionale Dei Tumori | Milano |
| Italy | Istituto Europeo di Oncologia | Milano |
| Japan, Tokyo | Local Institution - 501 | Chuo-ku |
| Japan, Tokyo | National Cancer Center Hospital | Chuo-ku |
| Japan, Tokyo | The Cancer Institute Hospital of Japanese Foundation For Cancer Research | Koto-ku |
| Japan, Tokyo | Local Institution - 502 | Koto |
| Japan | Local Institution - 500 | Kashiwa |
| Japan | National Cancer Center Hospital East | Kashiwa |
| Spain | Hospital Universitario Vall D hebron - PPDS | Barcelona |
| Spain | Fundacion Jimenez Daaz | Madrid |
| Spain | Hospital 12 de Octubre | Madrid |
| Spain | Hospital Universitario Marques de Valdecilla | Santander |
| United Kingdom | Local Institution - 300 | London |
| United Kingdom | Royal Marsden Hospital | London |
| United Kingdom | Freeman Hospital | Newcastle Upon Tyne |
| Sponsors and Collaborators |
| Celgene |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | |||||||||||
| Responsible Party : | Celgene | ||||||||||
| ClinicalTrials.gov Identifier : | NCT02875223 | ||||||||||
| Other Study ID Numbers : | CC-90011-ST-001 | ||||||||||
| First Posted : | August 23, 2016 | ||||||||||
| 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 |
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| Additional relevant MeSH terms : |
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