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

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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