Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT04089527|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
CC-95775-ST-001 is an open-label, Phase 1B, dose escalation and expansion study of CC-95775 in subjects with advanced or unresectable solid tumors, including laBCC, and relapsed/ refractory non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-95775 administered on a 4d on/24d off schedule to estimate the MTD of CC-95775. A mTPI-2 will help guide CC-95775 dose escalation decisions with the final decisions made by an SRC. Approximately 20 subjects will be enrolled.
The expansion cohort (Part B) will evaluate the safety, PK, PD safety and preliminary activity of CC-95775 in advanced solid tumors, including laBCC. Approximately 20 subjects will be enrolled.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Drug: CC-95775||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1B Dose-Escalation, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma|
|Estimated Study Start Date :||September 20, 2019|
|Estimated Primary Completion Date :||May 28, 2021|
|Estimated Study Completion Date :||April 18, 2023|
Escalating dose finding part A of study and extension Part B of the study. In Part A, subjects will be treated with oral capsules of CC-95775 with a schedule of 4d on/ 24d off (Q4W) and a starting dose of 100 mg/day on a 28-day cycle. Dose increments between cohorts will not exceed 100% of the dose in previous cohort. Patients in Part B will be treated with a schedule of 4d on/24d off (Q4W) at the Maximum tolerated dose (MTD) established from Part A.
- Dose Limiting Toxicity (DLT) [ Time Frame: C1 Up to approximately 28 days ]is defined as any toxicities occurring within the DLT assessment unless the event can clearly be determined to be unrelated to CC-95775.
- Maximum Tolerated Dose (MTD) [ Time Frame: Part A of the study- estimated 12 months ]dose level that could be given such that the estimated DLT probability is closest to 25%.
- Non-tolerated Dose (NTD) [ Time Frame: Part A of the study-estimated 12 months ]The dose that is higher than MTD
- Adverse Events (AEs) [ Time Frame: From signature of the informed consent until at least 28 days after the last dose of study treatment ]Number of participants with adverse event. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study
- Pharmacokinetics - Cmax of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months total ]Maximum plasma concentration of drug
- Pharmacokinetics - AUC of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months total ]Area under the curve
- Pharmacokinetics - Tmax of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months total ]Time to peak plasma concentration
- Pharmacokinetics - t1/2 of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months total ]Half-life the time it takes for the concentration of the drug in the plasma to be reduced by 50%
- Pharmacokinetics - CL/F of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months ]Measurement of the volume of plasma from which a substance is completely removed per unit time
- Pharmacokinetics - Vz/F of CC-95775 [ Time Frame: Part A and part B of the study, estimated 24 months ]Apparent volume of distribution. It is the volume needed to account for the total amount of drug in the body if the drug was evenly distributed throughout the body and in the same concentration as the site of sample collection such as peripheral venous plasma
- Evaluate the pharmacodynamic (PD) effects of CC-95775 on gene expression in peripheral blood and in tumor tissue. [ Time Frame: Part B of the study, estimated 12 months ]Changes in the expression of genes associated to BET inhibitors in PBMCs and/or other genes, such as GLI1, MYC, in tumor biopsy may provide confirmation that a dose is pharmacologically active and enable identification of dose, which results in optimal target engagement
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): NCT04089527
|Contact: Pilar Lardelli, MD PhD||34 email@example.com|
|Contact: Zariana Nikolova, MD PhD||41 firstname.lastname@example.org|
|Study Director:||Pilar Lardelli, MD PhD||Celgene|