Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma

Conditions

• Double-expressor Lymphoma (DEL)
• Double-hit Lymphoma (DHL)
• High-grade B-cell Lymphoma (HGBL)
• Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
• Refractory Lymphoma
• Relapsed Ddiffuse Large B-Cell Lymphoma (DLBCL)
• Relapsed Lymphoma
• Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
• Relapsed and/or Refractory Lymphoma
• Triple-hit Lymphoma (THL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• fimepinostat — DRUG
• Rituximab — DRUG
• venetoclax — DRUG

Study Details

This is a phase 1, open-label, dose-escalation study of fimepinostat (CUDC-907) in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 alterations. Fimepinostat (CUDC-907) is a multi-targeted agent designed to inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC). The study is designed to assess the safety, the maximum tolerated dose, the recommended phase 2 dose (RP2D), pharmacokinetics and the anti-cancer activity of oral fimepinostat in combination with 1 or more anti-cancer regimens.

Key Dates

First listed

Dec 6, 2012

Start date

Dec 31, 2012

Status verified

May 2021

Primary completion

Oct 9, 2020

Completion

Oct 9, 2020

Study Design

Enrollment

106 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fimepinostat - Continuous Once Daily
  Fimepinostat 30-60 mg/day
• Experimental: Fimepinostat - 2x/week
  Fimepinostat 60-240 mg/day
• Experimental: Fimepinostat - 3x/week
  Fimepinostat 60-180 mg/day
• Experimental: Fimepinostat - 4x/week
  Fimepinosta 60-180 mg/day
• Experimental: Fimepinostat - 5x/week
  Fimepinostat 60-180 mg/day
• Experimental: Fimepinostat - Expansion 5x/week
  Fimepinostat 60 mg on the 5 days on/2 days off
• Experimental: Fimepinostat - Expansion 3x/week
  Fimepinostat 120 mg 3 days on/4 days off
• Experimental: Fimepinostat 60 mg - Combination w/ rituximab
  Fimepinostat 60 mg 5 days on.2 days off plus rituximab
• Experimental: Fimepinostat 120 mg - Combination w/ rituximab
  Fimepinostat 120 mg 3x/week plus rituximab
• Experimental: Fimepinostat - Biocomparability Arm
  Biocomparability Arm
• Experimental: Fimepinostat 30 mg - Combination w/ venetoclax
  Fimepinostat 30 mg 5 days on/2 days off plus venetoclax. Different combinations of dose levels for venetoclax will be explored
• Experimental: Fimepinostat 60 mg - Combination w/ venetoclax
  Fimepinostat 60 mg 5 days on/2 days off plus venetoclax. Different combinations of dose levels for venetoclax will be explored
• Experimental: Fimepinostat - Combination w/ venetoclax and rituximab
  Fimepinostat and venetoclax dosed at dose levels determined for that combination. Rituximab dosed at 375 mg/m2 IV on Day 1 of each 21 day cycle

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral fimepinostat (CUDC-907) in combination with venetoclax and rituximab [ Time Frame: At the end of cycle 1 or 2 (each cycle is 21 days) ]

Locations (11)

Find similar trials in Los Angeles, CA

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