Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
NCT ID: NCT01742988
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
106 participants
INTERVENTIONAL
2012-12-31
2020-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fimepinostat - Continuous Once Daily
Fimepinostat 30-60 mg/day
fimepinostat
Fimepinostat - 2x/week
Fimepinostat 60-240 mg/day
fimepinostat
Fimepinostat - 3x/week
Fimepinostat 60-180 mg/day
fimepinostat
Fimepinostat - 4x/week
Fimepinosta 60-180 mg/day
fimepinostat
Fimepinostat - 5x/week
Fimepinostat 60-180 mg/day
fimepinostat
Fimepinostat - Expansion 5x/week
Fimepinostat 60 mg on the 5 days on/2 days off
fimepinostat
Fimepinostat - Expansion 3x/week
Fimepinostat 120 mg 3 days on/4 days off
fimepinostat
Fimepinostat 60 mg - Combination w/ rituximab
Fimepinostat 60 mg 5 days on.2 days off plus rituximab
fimepinostat
Rituximab
Fimepinostat 120 mg - Combination w/ rituximab
Fimepinostat 120 mg 3x/week plus rituximab
fimepinostat
Rituximab
Fimepinostat - Biocomparability Arm
Biocomparability Arm
fimepinostat
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
fimepinostat
venetoclax
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
fimepinostat
venetoclax
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
fimepinostat
Rituximab
Interventions
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fimepinostat
Rituximab
venetoclax
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease by CT or PET/CT. MRI acceptable as per protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments (excluding alopecia).
* Absolute neutrophil count ≥ 1,000/µL; platelets ≥ 75,000/µL for patients with no bone marrow involvement by malignancy; platelets ≥ 50,000/µL for patients with bone marrow involvement by malignancy.
* Creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN.
* Life expectancy of at least 3 months.
Exclusion Criteria
* SCT therapy within 100 days prior to starting study treatment.
* Systemic anti-cancer therapy or investigational agent within 3 weeks of study entry, except for nitrosoureas or mitomycin C (6 weeks).
* Other non-cytotoxic anti-cancer therapy or investigational agent within 5 half-lives or 21 days prior to study treatment, whichever is shorter, as long as any drug related toxicities have resolved to Grade 1 or less. Dexamethasone up to 12 mg/d is allowed as supportive therapy and does not exclude participation.
* Contraindication to venetoclax or rituximab.
* Progressive disease during treatment or within 3 months of stopping prior treatment with a BCL2 inhibitor, histone deacetylase (HDAC) inhibitor, or phosphoinositide-3 kinase (PI3k) inhibitor, or prior discontinuation of any of these therapies due to clinically significant toxicity.
* Graft vs. host disease following prior allogeneic transplant within 3 months prior to study treatment.
* Ongoing treatment with chronic immunosuppressants.
* Active CNS lymphoma.
* Known gastrointestinal condition that would interfere with swallowing or the oral absorption or tolerance of fimepinostat.
* Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
* Uncontrolled or severe cardiovascular disease
* Unstable or clinically significant concurrent medical condition.
* Second primary malignancy within 2 years of study entry other than what is specified in the protocol.
* Known HIV positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
* Active CMV infection, presence of CMV antigenemia, or evidence of any invasive CMV end organ disease (e.g., CMV colitis).
18 Years
ALL
No
Sponsors
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The Leukemia and Lymphoma Society
OTHER
Curis, Inc.
INDUSTRY
Responsible Party
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Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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References
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Oki Y, Kelly KR, Flinn I, Patel MR, Gharavi R, Ma A, Parker J, Hafeez A, Tuck D, Younes A. CUDC-907 in relapsed/refractory diffuse large B-cell lymphoma, including patients with MYC-alterations: results from an expanded phase I trial. Haematologica. 2017 Nov;102(11):1923-1930. doi: 10.3324/haematol.2017.172882. Epub 2017 Aug 31.
Younes A, Berdeja JG, Patel MR, Flinn I, Gerecitano JF, Neelapu SS, Kelly KR, Copeland AR, Akins A, Clancy MS, Gong L, Wang J, Ma A, Viner JL, Oki Y. Safety, tolerability, and preliminary activity of CUDC-907, a first-in-class, oral, dual inhibitor of HDAC and PI3K, in patients with relapsed or refractory lymphoma or multiple myeloma: an open-label, dose-escalation, phase 1 trial. Lancet Oncol. 2016 May;17(5):622-31. doi: 10.1016/S1470-2045(15)00584-7. Epub 2016 Mar 31.
Other Identifiers
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CUDC-907-101
Identifier Type: -
Identifier Source: org_study_id
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