Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral fimepinostat (CUDC-907) in combination with venetoclax and rituximab	At the end of cycle 1 or 2 (each cycle is 21 days)	To be evaluated in patients with relapsed and/or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Within any given study arm, the highest dose level studied at which fewer than 2 out of 6 subjects (\< 33%) experience a dose limiting toxicity (DLT).
Primary	To assess the safety and tolerability of fimepinostat in combination with anti-cancer regimens by evaluating the number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0).	18 months	Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0).
Primary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens by evaluating ORR	24 months	ORR assessments as measured using Lugano criteria.
Primary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens by evaluating DOR	24 months	DOR assessments as measured using Lugano criteria.
Secondary	To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by area under the concentration-time curve (AUC).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
Secondary	To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by maximum plasma concentration (Cmax).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include maximum plasma concentration (Cmax).
Secondary	To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by half-life (T1/2).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include half-life (T1/2).
Secondary	To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by clearance (Cl).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include clearance (Cl).
Secondary	To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by volume of distribution (Vd).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include volume of distribution (Vd).
Secondary	To assess PK of venetoclax when administered in combination with fimepinostat as measured by area under the concentration-time curve (AUC).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
Secondary	To assess PK of venetoclax when administered in combination with fimepinostat as measured by maximum plasma concentration (Cmax).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include maximum plasma concentration (Cmax).
Secondary	To assess PK of venetoclax when administered in combination with fimepinostat as measured by half-life (T1/2).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include half-life (T1/2).
Secondary	To assess PK of venetoclax when administered in combination with fimepinostat as measured by clearance (Cl).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include clearance (Cl).
Secondary	To assess PK of venetoclax when administered in combination with fimepinostat as measured by volume of distribution (Vd).	Pre-dose to 21 - 28 days post dose	Pharmacokinetic parameters will include volume of distribution (Vd).
Secondary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens as measured by OS.	24 months	OS measured using RECIL 2017 criteria and revised RECIST 1.1.
Secondary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens as measured by PFS.	24 months	PFS measured using RECIL 2017 criteria and revised RECIST 1.1.
Secondary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens as measured by ORR.	24 months	ORR measured using RECIL 2017 criteria and revised RECIST 1.1.
Secondary	To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens as measured by DOR.	24 months	DOR measured using RECIL 2017 criteria and revised RECIST 1.1.
Secondary	To evaluate biomarkers of fimepinostat activity	24 months	Exploratory biological markers of fimepinostat activity will be assessed in PBMCs, plasma, and tumor and samples to explore biomarkers that correlate with safety and/or efficacy, such as CREBBP/EP300.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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