E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

NCT00413192 | Completed Phase 2 Results

• 2 other identifiers: E7389-E044-2072005-004272-20
• Study Type: interventional
• Target: 128
• Locations: 5 countries
• Sites: 15

Brief Summary

The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) at 12 Weeks

  PFS was determined from the Week 12 visit tumor scan and the participant's date of death. Progression was defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death from any cause, or not assessable according to Response Evaluation Criteria In Solid Tumors (RECIST). CR defined as the loss of all target lesions. PR defined as ≥ 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PD defined as ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since treatment started. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided confidence intervals (CIs) for the percentage of successes.

  Week 12

Secondary Outcomes (7)

• Overall Progression Free Survival

  First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years

• Objective Response Rate (ORR)

  Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years

• Clinical Response Benefit (CRB)

  Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years

• Time to Onset of Response

  Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years

• Duration of Response

  Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years

Study Arms (1)

1

EXPERIMENTAL

Drug: E7389

Interventions

E7389 DRUG

1.4 mg/m\^2 administered as an intravenous (I.V.) bolus infusion on Days 1 and 8 of every 21 days.

1

Eligibility Criteria

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

You may qualify if:

• Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies (World Health Organization (WHO) classification 2002):
• Leiomyosarcoma
• Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type not otherwise specified)
• Synovial sarcoma
• Other types of sarcoma, including:
• Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma).
• So-called fibrohistiocytic (pleomorphic Malignant Fibrous Histiocytoma (MFH), giant cell "MFH", inflammatory "MFH")
• Malignant glomus tumors.
• Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal rhabdomyosarcoma.
• Vascular (epithelioid haemangioendothelioma, angiosarcoma).
• Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor (PEComa), intimal sarcoma) excluding chondrosarcoma, Ewing tumors / Primitive neuroectodermal tumor (PNET)
• Malignant peripheral nerve sheath tumors.
• Malignant solitary fibrous tumors.
• Undifferentiated soft tissue sarcomas not otherwise specified.
• Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration).

You may not qualify if:

• Prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has been free of any other malignancies for \> 3 years).
• Significant cardiovascular impairment (history of congestive heart failure \> New York Heart Association (NYHA) grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).
• Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) / international normalized ratio (INR) must be closely monitored.
• Severe/uncontrolled intercurrent illness/infection.
• Patients with a known hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
• Patients who participated in a prior E7389 clinical trial.
• Patients without freedom (by the law or administrative decision), hospitalized without their consent (mental disability, upon legal request), admitted in medical or social establishment for other reasons than clinical research, with any psychological, familial, sociological, geographical condition potentially hampering compliance with the study protocol and follow-up schedule ; those conditions should be assessed with the patient before registration in the trial.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (15)

Unknown Facility

Brussels, BE 1000, Belgium

Location

Unknown Facility

Leuven, BE 3000, Belgium

Location

Unknown Facility

Aarhus, DK 8000, Denmark

Location

Unknown Facility

Herlev, DK 2730, Denmark

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Lyon, 69008, France

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Bad Saarow, 15526, Germany

Location

Unknown Facility

Dresden, DE 01307, Germany

Location

Unknown Facility

Essen, DE 45122, Germany

Location

Unknown Facility

Hanover, DE 30625, Germany

Location

Unknown Facility

Mannheim, DE 68135, Germany

Location

Unknown Facility

Tübingen, DE 72076, Germany

Location

Unknown Facility

Warsaw, 02 781, Poland

Location

Related Publications (2)

• Wiemer EAC, Wozniak A, Burger H, Smid M, Floris G, Nzokirantevye A, Sciot R, Sleijfer S, Schoffski P. Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: Translational results of the EORTC 62052 trial. Eur J Cancer. 2017 Apr;75:33-40. doi: 10.1016/j.ejca.2016.12.018. Epub 2017 Feb 16.

  PMID: 28214655 DERIVED

• Schoffski P, Ray-Coquard IL, Cioffi A, Bui NB, Bauer S, Hartmann JT, Krarup-Hansen A, Grunwald V, Sciot R, Dumez H, Blay JY, Le Cesne A, Wanders J, Hayward C, Marreaud S, Ouali M, Hohenberger P; European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011 Oct;12(11):1045-52. doi: 10.1016/S1470-2045(11)70230-3. Epub 2011 Sep 19.

  PMID: 21937277 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Gitta Irmer Associate Director, Data Quality & Standards Global Regulatory Operations
• Organization: Eisai Ltd. Mosquito Way, Hatfield, Hertfordshire, AL 10 9SN

+44 (0) 845 676 1618

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: January 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 26, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-01

Locations

DK (2); FR (4); BE (2); DE (6); PL (1)