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 : December 4, 2018
|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 consent 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 in each 28-day cycle. Alternative dosing schedules (eg, 2-days- on/5-days- off each week, 3-days-on/4-days-off every other week, 2-weeks-on/2-weeks-off, 4-days on/24 days off, 5-days on/23-days- off, etc.) 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.
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 :||May 13, 2020|
|Estimated Study Completion Date :||April 15, 2022|
Experimental: CC-90010 in patients with solid tumors and NHL
Subjects will administer CC-90010 starting on Day 1 for 3 consecutive days followed by 4 consecutive days off drug every week (3/7-days schedule) in each 28 day cycle.
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 3 years ]Number of participants with adverse events
- Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 18 months ]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 3 years ]Maximum observed plasma concentration
- Pharmacokinetic- AUC [ Time Frame: Up to 3 years ]Area under the plasma concentration time-curve
- Pharmacokinetic- Tmax [ Time Frame: Up to 3 years ]Time to maximum plasma concentration
- Pharmacokinetic- t1/2 [ Time Frame: Up to 3 years ]Terminal half-life
- Pharmacokinetic- CL/F [ Time Frame: Up to 3 years ]Apparent clearance
- Pharmacokinetic- Vz/F [ Time Frame: Up to 3 years ]Apparent volume of distribution
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 Disclosurefirstname.lastname@example.org|
|Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest||Not yet recruiting|
|Bordeaux, France, 33076|
|Institut Gustave Roussy Hematologie||Not yet recruiting|
|Villejuif, France, 94805|
|Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)||Not yet recruiting|
|Meldola, Italy, 47014|
|Humanitas Clinical and Research Center Gastrointestinal Immunopathology Lab and IBD Unit||Not yet recruiting|
|Milan, Italy, 20089|
|Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale||Not yet recruiting|
|Napoli, Campania, Italy, 80131|
|Hospital Vall 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|