Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

• Register: ANZCTR
• Last refreshed on: 18 March 2013
• Main ID: ACTRN12611001074987
• Date of registration: 17/10/2011
• Primary sponsor: Commercial sector/Industry Eisai Limited
• Public title: Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
• Scientific title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
• Date of first enrolment: 22/03/2011
• Target sample size: 450
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12611001074987.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Argentina, Australia,Outside, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Korea, Republic Of, Netherlands, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Thailand, United Kingdom, United States of America

Contacts

• Name: Ms Xui Ming Lee

• Name: Dr Wouter Hanekom

Key inclusion & exclusion criteria

Inclusion criteria: 1. Histologically confirmed diagnosis of soft tissue sarcoma of high or intermediate grade with one of the following histological subtypes: a. Adipocytic sarcoma b. Leiomyosarcoma. 2. Documented evidence of advanced adipocytic or leiomyosarcoma, incurable by surgery and/or radiotherapy. 3. Subjects should have received at least two standard systemic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline (unless contraindicated). 4. Radiographic evidence of disease progression within the 6 months prior to randomization. 5. Presence of measurable disease. 6. Eastern Cooperative Oncology Group, performance status of 0, 1 or 2. 7. Adequate renal function. 8. Adequate bone marrow function. 9. Adequate liver function.
Exclusion criteria: 1. Subjects who have received any anti-cancer therapy, including surgery or intratumoral therapy, radiotherapy, chemotherapy, hormonal, biological, immunotherapy and targeted agents within 21 days, or five half-lives of the drug (whichever is longer), prior to randomization. 2. Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to =/< Grade 1. 3. Subjects that have previously been treated with dacarbazine or participated in a study with eribulin. 4. Pre-existing peripheral neuropathy > CTCAE Grade 2. 5. Significant cardiovascular impairment. 6. Subjects with a high probability of Long QT Syndrome. 7. Subjects with known central nervous system metastases.

Age minimum: 18 Years
Age maximum: 0 No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Soft tissue sarcoma

Intervention(s)

Administration of eribulin mesylate at a dose of 1.4 mg/m2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days. Treatment will continue until disease progression, development of unacceptable toxicity or withdrawal of consent.

Primary Outcome(s)

Overall survival measured from the date of randomisation until date of death from any cause.

Secondary Outcome(s)

To compare progression-free survival (PFS) between Arm A and Arm B.

Secondary ID(s)

ClinicalTrials.gov Identifier: NCT01327885

Source(s) of Monetary Support

Eisai Limited

Secondary Sponsor(s)

Eisai Inc