E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

NCT01401530 | Completed Phase 1 Results

• 1 other identifier: E7777-J081-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.

Conditions

Peripheral T-Cell Lymphoma

Keywords

Neoplasms; Neoplasms by Histologic Type; Lymphoma; Non-Hodgkin; T- Cell; Lymphatic Diseases; Lymphoproliferative Disorders; lmmune System Diseases; lmmunoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) and Recommended Dose (RD)

  The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.

  For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)

Secondary Outcomes (11)

• Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox

  From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months

• Maximum Serum Concentration (Cmax) of Denileukin Diftitox

  Cycle 1 (Day 1)

• Time to Cmax (Tmax) of Denileukin Diftitox in Serum

  Cycle 1 (Day 1)

• Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))

  Cycle 1 (Day 1)

• Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf))

  Cycle 1 (Day 1)

Study Arms (1)

E7777

EXPERIMENTAL

Biological: denileukin diftitox (E7777)

Interventions

denileukin diftitox (E7777) BIOLOGICAL

E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.

E7777

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Brain metastasis with clinical symptoms which requires treatment
• Serious systemic infection requiring intensive treatment
• Serious complications or histories
• History of hypersensitivity to protein therapeutics
• Known to be positive for HIV antibody, HCV antibody, or HBs antigen
• History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
• Patients who have undergone allogeneic hematopoietic stem cell transplantation
• Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Kashiwa, Chiba, Japan

Location

Unknown Facility

Isehara, Kanagawa, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Related Publications (1)

• Ohmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26.

  PMID: 29363235 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Neoplasms; Neoplasms by Histologic Type; Lymphoma; Lymphatic Diseases; Lymphoproliferative Disorders

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Eisai Medical Services Inc.
• Organization: Eisai Inc.

esi_medinfo@eisai.com

1-888-422-4743

Study Officials

• Tadashi Nakanishi

  Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-04

Locations

JP (4)