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Romidepsin

Phase 1

Peripheral T Cell Lymphoma | Small molecule | Oncology |Amgen Inc.|Last Updated: May 18, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Romidepsin · 1 trial · 1 indication

Phase 1 1
NCT03141203Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma PatientsPeripheral T Cell Lymphoma
COMPLETED50 Analytics
PHASE1COMPLETED
Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients
Peripheral T Cell Lymphoma
NCT0314120350
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Study Endpoints

Primary Endpoints

Maximum Tolerated Dose of the combination of romidepsin and carfilzomib
Cycle 1 (each cycle is 28 days)

MTD as determined by the continual reassessment model (CRM) with a predefined target Dose Limiting Toxicity (DLT) probability of 25%

Best overall response rate (PR + CR) at the MTD
Data will be collected over the first 8 cycles of therapy (each cycle is 28 days)

Assessed using the International response criteria

Secondary Endpoints

Toxicity of the combination of romidepsin and carfilzomib
Adverse events information will be collected throughout the 36 month recruitment period of the trial and during the one year follow up period
Best overall response at the MTD
Information relating to this outcome will be collected up to and including the one year follow-up time point
Maximum percentage change in the radiological sum of the product of the diameters from baseline, assessed using the Revised Response Criteria for Malignant Lymphoma
Information relating to this outcome will be collected up to and including the one year follow-up time point
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Level 1EXPERIMENTAL8mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/36mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.
Dose Level 2 (starting dose)EXPERIMENTAL10mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/36mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.
Dose Level 3EXPERIMENTAL10mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/45mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.
Dose Level 4EXPERIMENTAL12mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/45mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.
Dose Level 5EXPERIMENTAL12mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/56mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.
Dose Level 6EXPERIMENTAL14mg/m2 Romidepsin (administered on days 1, 8, 15) and 20/56mg/m2 Carfilzomib (administered days 1, 2, 8, 9, 15, 16) over 8 cycles of treatment. Carfilzomib dose will be 20mg/m2 for the first 2 doses (i.e. day 1 and 2 of cycle 1), rising to the target dose for subsequent doses and cycles.

Interventions

NameTypeDescription
RomidepsinDRUG10mg vial for Injection
CarfilzomibDRUG60mg vial for injection
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Age ≥ 16 years of age * Life expectancy \> 12 weeks * ECOG performance status ≤ 2 * Relapsed or refractory peripheral T-cell lymphoma including the following histologies: peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large c...

Countries:United Kingdom
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