The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Capsule for oral administration
Tablet for oral administration
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)
This will be evaluated by looking at the number of participants with treatment-related adverse events, serious adverse events (SAEs), and dose-limiting toxicities (DLTs), which are medical problems severe enough to stop study doctors from increasing a treatment dose.
Time frame: Up to 54 months
Phase 2: Antitumor Activity Assessed by Overall Response Rate (ORR) Based on 2014 Lugano Classification Using Computerized Tomography (CT) Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 1: Number of Participants With TEAEs, SAEs and DLTs in the Oral Decitabine/Cedazuridine Arm
Time frame: Up to 54 months
Ph 1 & 2: AUC: Area Under the Plasma Concentration-Time Curve
Time frame: Up to 50 months
Ph 1 & 2: Cmax: Maximum Observed Plasma Concentration
Time frame: Up to 50 months
Ph 1 & 2: Cmin: Minimum Observed Plasma Concentration at Steady State
Time frame: Up to 50 months
Ph 1 & 2: Tmax: Time to Maximum Observed Plasma Concentration
Time frame: Up to 50 months
Ph 1 & 2: t½: Apparent Elimination Half-Life
Time frame: Up to 50 months
Phase 2: Duration of response (DOR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
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City of Hope Site #151
Duarte, California, United States
University of Califonia, Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Colorado Anschutz Medical Campus Site #118
Aurora, Colorado, United States
Yale Cancer Center Site #109
New Haven, Connecticut, United States
Moffitt Cancer Center Site #157
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute Site#159
Detroit, Michigan, United States
...and 36 more locations
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Complete Response (CR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Partial Response (PR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Progression-Free Survival (PFS) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Disease Control Rate (DCR) Assessed as Percentage of Participants With Disease Control Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Overall Survival (OS) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Percentage of Participants With DOR, CR, PR, PFS, DCR,and OS Based on the Lugano Classification Using CT Along With PET Imaging Assessments
Duration of response (DOR), complete response (CR), partial response (PR), progression-free survival (PFS), disease control rate (DCR)and overall survival (OS)
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Anti-Tumor Activity Based on Assessment Using 2014 Lugano Classification With Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Anti-tumor activity in terms of ORR, DOR, CR, PR, and PFS will be evaluated based on assessment using 2014 Lugano Classification with LYRIC.
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Anti-Tumor Activity Based on PTCL Subtypes Anti-tumor activity in terms of ORR, DOR, DCR, CR, and PR will be evaluated based on PTCL subtypes (using both pathology and molecular markers).
Time frame: Up to 54 months