Lymphoma, Non-HodgkinPhase 1NCT02875223
A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
A Phase 1 study testing CC-90011, Rifampicin and Itraconazole in people with Lymphoma, Non-Hodgkin and Neoplasms, run by Celgene at 15 sites in 5 countries.
Trial 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]… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Neoplasms
- What is being tested?
- CC-90011, Rifampicin and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 31 Aug 2016to 25 Mar 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain4 sites
Local Institution - 400
Barcelona, 08035
Local Institution - 402
Madrid, 28040
Local Institution - 404
Madrid, 28041
Local Institution - 401
Santander, 39008
France3 sites
Local Institution - 101
Dijon, 21079
Local Institution - 102
Marseille, 13273
Local Institution - 100
Villejuif, 94805
Italy3 sites
Local Institution - 200
Bologna, 40123
Local Institution - 201
Milan, 20133
Local Institution - 202
Milan, 20141
Japan3 sites
Local Institution - 501
Chuo-ku, Tokyo, 104-0045
Local Institution - 500
Kashiwa, 277-8577
Local Institution - 502
Koto-Ku, Tokyo, 135-8550
United Kingdom2 sites
Local Institution - 300
London, SW3 6JJ
Local Institution - 301
Newcastle upon Tyne, NE7 7DN
About this study
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 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.
- Conditions
- Lymphoma, Non-Hodgkin, Neoplasms
- Being tested
- CC-90011, Rifampicin, Itraconazole
- 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
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90011Drug
Specified dose on specified days
RifampicinDrug
Specified dose on specified days
ItraconazoleDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| CC-90011 and Rifampicin | Experimental | Not described Receives: Drug: CC-90011; Drug: Rifampicin |
| CC-90011 and Itraconazole | Experimental | Not described Receives: Drug: CC-90011; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
Measured: Cycle 1 (Each cycle is of 28 days)
Part A - Maximum Tolerated Dose (MTDs)
The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.
Measured: Cycle 1 (Each cycle is of 28 days)
Secondary outcomes (16)
Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical benefit rate (CBR) is defined as percentage of participants with tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)
Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percentage of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)
Part A - Duration of Response (DoR) Based on Confirmed Responses
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Progression-Free Survival (PFS)
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 based on Kaplan-Meier methodology. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
Measured: From first dose (Day 1) until death due to any cause (up to 803 days)
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Blood samples were collected to assess Cmax. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Blood samples were collected to assess AUCt. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Time to Cmax (Tmax) of CC-90011
Blood samples were collected to assess Tmax. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Half-life (t1/2) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Apparent Clearance (CL/F) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A- Volume of Distribution (Vz/F) of CC-90011
Blood samples were collected to assess Vz/F. Prespecified to be reported for Part A only.
Measured: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part B - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical Benefit Rate (CBR) is defined as tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Objective Response Rate as Per Confirmed Best Overall Response Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percent of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) till disease progression or death due to any cause (up to 720 days)
Part B - Duration of Response (DoR)
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Progression Free Survival (PFS)
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 based on Kaplan-Meier methodology Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Measured: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
Measured: From first dose (Day 1) until death due to any cause (up to 720 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start31 Aug 2016
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875223
- Sponsor's protocol ID
- CC-90011-ST-001
- Status last verified
- Apr 2025
- First submitted
- 18 Aug 2016
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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, 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.
PubMed 33046517Hollebecque 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.
PubMed 35737639
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02875223
- Acronym / sponsor ID
- CC-90011-ST-001
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-90011 and Rifampicin | Experimental | Drug: CC-90011, Drug: Rifampicin |
| CC-90011 and Itraconazole | Experimental | Drug: CC-90011, Drug: Itraconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-90011Specified dose on specified days | Drug | CC-90011 and Itraconazole, CC-90011 and Rifampicin |
| RifampicinSpecified dose on specified days | Drug | CC-90011 and Rifampicin |
| ItraconazoleSpecified dose on specified days | Drug | CC-90011 and Itraconazole |
Primary outcome
Part A - Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Each cycle is of 28 days)
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
Part A - Maximum Tolerated Dose (MTDs)
Time frame: Cycle 1 (Each cycle is of 28 days)
The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.
16 secondary outcomes
Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
Time frame: From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)
Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
Time frame: From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)
Part A - Duration of Response (DoR) Based on Confirmed Responses
Time frame: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Progression-Free Survival (PFS)
Time frame: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Overall Survival (OS)
Time frame: From first dose (Day 1) until death due to any cause (up to 803 days)
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Time to Cmax (Tmax) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Half-life (t1/2) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Apparent Clearance (CL/F) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A- Volume of Distribution (Vz/F) of CC-90011
Time frame: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part B - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
Time frame: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Objective Response Rate as Per Confirmed Best Overall Response Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
Time frame: From first dose (Day 1) till disease progression or death due to any cause (up to 720 days)
Part B - Duration of Response (DoR)
Time frame: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Progression Free Survival (PFS)
Time frame: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Overall Survival (OS)
Time frame: From first dose (Day 1) until death due to any cause (up to 720 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33046517Hollebecque 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.
- Derived from this study: PubMed 35737639Hollebecque 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90011, Rifampicin and Itraconazole in people with Lymphoma, Non-Hodgkin and Neoplasms, run by Celgene at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, France, Italy, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (Each cycle is of 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875223, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.