CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Eribulin +1 moredrug
Likely dose
Not stated in 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/NCT01554371
NCT01554371Phase 2Completed

A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

University of California, San Francisco·interventional·Posted Mar 15, 2012·Updated Feb 3, 2021

In Brief

A Phase 2 clinical trial evaluating Eribulin and Cyclophosphamide for Malignant Solid Tumour and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA. The funding for this study is provided by Eisai Inc., the maker of eribulin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2012
Enrollment StartMar 27, 2012
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 14.3 years ago

Interventions

Eribulindrug

Given intravenously (IV) Phase II: Eribulin mesylate (mg/m2) + Cyclophosphamide (mg/ m2) for advanced breast cancer participants only

Cyclophosphamidedrug

Given IV