CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 112 enrolled
Drug / intervention
E7777 9 mcg/kgdrug
Likely dose
E7777 9 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01871727
NCT01871727Phase 3Completed
CompareCT.gov

A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

Eisai Inc.·interventional·Posted Jun 7, 2013·Updated Nov 13, 2024

In Brief

A Phase 3 clinical trial evaluating E7777 9 mcg/kg for Persistent or Recurrent Cutaneous T-Cell Lymphoma. Completed, enrolled 112 participants across 22 sites in 3 countries.

Detailed Summary

The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent or Recurrent Cutaneous T-Cell Lymphoma
CountriesAustralia, Puerto Rico, United States
CollaboratorsDr. Reddy's Laboratories Limited, Citius Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 7, 2013
Enrollment StartMay 30, 2013
Primary CompletionDec 6, 2021
Study CompletionDec 14, 2021
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 13.1 years ago

Interventions

E7777 9 mcg/kgdrug

administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days