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Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL

NCT01897571 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-03-26

Study results available
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Summary

This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

Conditions

  • B-cell Lymphomas (Phase 1)
  • Advanced Solid Tumors (Phase 1)
  • Diffuse Large B-cell Lymphoma (Phase 2)
  • Follicular Lymphoma (Phase 2)
  • Transformed Follicular Lymphoma
  • Primary Mediastinal Large B-Cell Lymphoma

Interventions

DRUG

Tazemetostat

Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.

DRUG

Prednisolone

Patients who received 40 mg/m\^2 prednisolone once daily on Days 1-5 and 15-19 of Cycles 1-4.

DRUG

Tazemetostat

Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.

Sponsors & Collaborators

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-13
Primary Completion
2021-08-24
Completion
2021-11-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897571 on ClinicalTrials.gov