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

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001074987

Enrollment

452

Registered

2011-10-17

Start date

2011-03-22

Completion date

2013-05-28

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following at least 2 standard systemic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline, unless contraindicated.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results