A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas
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|ClinicalTrials.gov Identifier: NCT03220347|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Neoplasms||Drug: CC-90010||Phase 1|
Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up.
The Screening Period starts 28 days (± 3 days) prior to first dose of CC-90010. The informed document (ICD) must be signed and dated by the subject and the administering staff prior to the start of any other study procedures. All screening tests and procedures must be completed within the 28 days (±3 days) prior to the first dose of CC-90010.
During the Treatment Period, CC-90010 will initially be administered orally once daily for 3 consecutive days followed by 4 consecutive days off drug every week (3/7-days schedule) in each 28-day cycle in Part A. Alternative dosing schedules (eg, 2-days-on/5-days- off each week, 3-days-on/4-days-off every other week, 4-days on/24 days off) may be evaluated one dosing schedule at a time or ≥ 2 dosing schedules given in parallel, based on the review of available safety, PK, pharmacodynamic (PD), and efficacy data by the SRC.
Following completion of dose escalation in Part A, selected expansion cohorts of up to approximately 20-25 efficacy evaluable subjects per cohort will receive CC-90010 in Part B. Expansion may occur at the MTD established in Part A and/or at a lower dose, or an alternative tolerable dosing schedule, based on review of available safety, PK, and PD data. The SRC determined the RP2D for Part B to be 45 mg CC-90010 given once daily for 4 consecutive days on followed by 24 consecutive days off (4-days-on/24-days-off) in each 28-day cycle. Two cohorts of up to approximately 20-25 subjects each with relapsed and/or refractory DLBCL (Cohort 1) and advanced basal cell carcinoma (BCC) (Cohort 2) will be enrolled in Part B expansion.
In the Follow-up Period, subjects will be followed for 28 days (± 3 days) after the last dose of CC-90010 for safety.
After the Safety Follow-up visit, all subjects will be followed every subsequent 3 months (± 2 weeks) for survival follow-up for up until 2 years or until death, lost to follow-up, or the End of Trial, whichever occurs first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||August 23, 2021|
|Estimated Study Completion Date :||August 23, 2023|
Experimental: CC-90010 in patients with solid tumors and NHL
Subjects will be administered orally once daily for 3 consecutive days followed by 4 consecutive days off drug every week (3/7-days schedule) in each 28 day cycle in Part A. Alternative dosing schedules (eg, 2-days-on/5-days- off each week, 3-days-on/4-days-off every other week, 4-days on/24 days off) may be evaluated one dosing schedule at a time or ≥ 2 dosing schedules given in parallel, based on the review of available safety, PK, pharmacodynamic (PD), and efficacy data.
CC-90010 is an oral, potent and reversible inhibitor of the epigenetic target bromodomain and extra-terminal (BET) proteins.
- Adverse Events (AEs) [ Time Frame: Up to 5 years ]Number of participants with adverse events
- Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 5 years ]A DLT is defined as any of the toxicities described in the protocol occurring within the DLT assessment unless the event can clearly be determined to be unrelated to CC-90010
- Maximum tolerated dose (MTD) [ Time Frame: Up to 2 years ]The MTD is the highest dose that causes DLTs in not more than 33% of the subjects treated with CC-90010 in the first cycle with at least 6 evaluable subjects treated at this dose.
- Clinical benefit rate (CBR) [ Time Frame: Up to 5 years ]Is defined as tumor responses (as assessed by the Investigators) of complete response (CR), partial response (PR) and stable disease (SD) (SD of ≥ 4 months duration).
- Objective response rate (ORR) [ Time Frame: Up to 5 years ]Is defined as the percent of subjects whose best response is CR or PR.
- Duration of Response Rate [ Time Frame: Up to 5 years ]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
- Duration of stable disease [ Time Frame: Up to 5 years ]For subjects with best response of SD, duration of SD is measured from the first dose date until the criteria for progression are met
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ]Is defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause.
- Overall survival [ Time Frame: Up to 5 years ]Is measured as the time from the first dose of CC-90010 to death due to any cause.
- Pharmacokinetic- Cmax [ Time Frame: Up to 5 years ]Maximum observed plasma concentration on first and last day of dosing within a cycle
- Pharmacokinetic- AUC [ Time Frame: Up to 5 years ]Area under the plasma concentration time-curve on first and last day of dosing within a cycle
- Pharmacokinetic- Tmax [ Time Frame: Up to 5 years ]Time to maximum plasma concentration on first and last day of dosing within a cycle
- Pharmacokinetic- t1/2 [ Time Frame: Up to 5 years ]Terminal half-life on last day of dosing within a cycle
- Apparent Clearance [ Time Frame: Up to 5 years ]Apparent total systemic clearance to be estimated following the last dose in cycle 1
- Apparent Volume of Distribution [ Time Frame: Up to 5 years ]Apparent steady state volume of distribution to be estimated following the last dose in cycle 1
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): NCT03220347
|Contact: Associate Director, Clinical Trial Disclosureemail@example.com|
|Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest||Recruiting|
|Bordeaux, France, 33076|
|Gustave Roussy - Cancer Campus||Recruiting|
|Villejuif, France, 94805|
|Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)||Recruiting|
|Meldola, Italy, 47014|
|Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale||Recruiting|
|Napoli, Campania, Italy, 80131|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano (MI), Italy, 20089|
|Aichi Cancer Center Hospital||Not yet recruiting|
|Chikusa-ku, Japan, 464-8681|
|National Cancer Center Hospital East||Not yet recruiting|
|Kashiwa, Japan, 277-8577|
|The Cancer Institute Hospital of Japanese Foundation For Cancer Research||Not yet recruiting|
|Koto-ku, Japan, 135-8550|
|Hospital Val d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Hospital Universitario Fundacion Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Hospital 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Study Director:||Zariana Nikolova, MD, PhD||Celgene|