A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
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|ClinicalTrials.gov Identifier: NCT02875223|
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Neoplasms||Drug: CC-90011||Phase 1|
Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days (± 3 days) prior to first dose of CC-90011. The informed consent form (ICF) 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-90011.
Treatment Period During the Treatment Period, CC-90011 will initially be administered orally in each 4-week (28 day) Cycle in Part A.
In September 2018, after completion of Part A, the SRC determined the RP2D to be 60 mg CC 90011 once weekly (QW) in each 28-day cycle. In Part B, 3 cohorts, of approximately 10-20 evaluable subjects each, with advanced low/intermediate-grade lung NETs, NEPCs, R/R NHL (MZL, including transformed MZL) will receive the RP2D to further evaluate safety, PK, PD and preliminary efficacy.
Follow-up Period In the Follow-up Period, subjects will be followed for 28 days (± 3 days) after the last dose of CC-90011 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 :||76 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, Pharmacokinetic and Preliminary Efficacy of CC-90011 in Subjects With Advanced Solid Tumors and Non-Hodgkin Lymphomas|
|Actual Study Start Date :||August 23, 2016|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 7, 2023|
Experimental: CC-90011 Administration
Subjects will administer CC-90011 orally once weekly in each 4 -week (28 day) Cycle. Alternative dosing schedules may be implemented based on the review of clinical safety and laboratory data by the SRC. CC-90011 will be administered with at least 240 mL of water. Subjects should fast for a minimum of 4 hours in both Parts A and B prior to CC-90011 administration and refrain from any food intake for up to 1 hour after dosing
- Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]Number of participants with DLT
- Adverse Events (AEs) [ Time Frame: Up to 6 years ]Number of participants with adverse events
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 6 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 6 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 6 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 6 years ]Is measured as the time from the first dose of CC-90011 to death due to any cause.
- Pharmacokinetics ‐ Cmax [ Time Frame: Up to 6 years ]Maximum observed plasma concentration
- Pharmacokinetics ‐ AUC [ Time Frame: Up to 6 years ]Area under the plasma concentration time-curve
- Pharmacokinetics ‐Tmax [ Time Frame: Up to 6 years ]Time to maximum plasma concentration
- Pharmacokinetics ‐t1/2 [ Time Frame: Up to 6 years ]Terminal half-life
- Pharmacokinetics ‐CL/F [ Time Frame: Up to 6 years ]Apparent total body clearance
- Pharmacokinetics ‐Vz/F [ Time Frame: Up to 6 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): NCT02875223
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Centre Georges Francois Leclerc||Recruiting|
|Dijon, France, 21079|
|Institut Paoli Calmettes||Recruiting|
|Marseille Cedex 9, France, 13273|
|Villejuif Cedex, France, 94805|
|Bologna, Italy, 40123|
|Istituto Nazionale Dei Tumori||Recruiting|
|Milano, Italy, 20133|
|Istituto Europeo di Oncologia||Recruiting|
|Milano, Italy, 20141|
|Hospital Universitario Vall D hebron||Recruiting|
|Barcelona, Spain, 08035|
|Fundacion Jimenez Daaz||Recruiting|
|Madrid, Spain, 28040|
|Hospital Universitario Marques de Valdecilla||Recruiting|
|Santander, Spain, 39008|
|Royal Marsden Hospital||Recruiting|
|London, United Kingdom, SW3 6JJ|
|Newcastle Upon Tyne, United Kingdom, NE7 7DN|
|Study Director:||Zariana Nikolova, MD, PhD||Celgene Corporation|
|Principal Investigator:||Johann De Bono, MD, PhD||Royal Marsden NHS Foundation Trust|
|Principal Investigator:||Antoine Hollebecque, MD||Gustave Roussy, Cancer Campus, Grand Paris|