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NCT01676818

Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

Completed Phase 2 Results posted Last updated 6 November 2025
What this trial tests

Phase 2 trial testing eribulin mesylate in Recurrent Cervical Cancer in 32 participants. Completed in 22 December 2021.

Timeline
9 August 2012
Primary endpoint
21 February 2021
22 December 2021

Quick facts

Lead sponsorUniversity of Southern California
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment32
Start date9 August 2012
Primary completion21 February 2021
Estimated completion22 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Southern California

Who can join

18 and older, female only, with Recurrent Cervical Cancer or Stage IIIA Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival Primary · From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months

Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.

GroupValue95% CI
Eribulin Mesylate2.51.2 – 4.2
Number of Participants With Serious Adverse Events (SAEs) Primary · At study drug administration until 30 days following the last dose. Assessed up to 2 years.

Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.

GroupValue95% CI
Eribulin Mesylate25
Best Overall Response (BOR) Secondary · Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.

BOR is defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions f

GroupValue95% CI
Eribulin Mesylate1
Eribulin Mesylate5
Eribulin Mesylate13
Eribulin Mesylate11
Overall Survival (OS) Secondary · From first day of treatment to time of death due to any cause, assessed up to 2 years

Overall survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.

GroupValue95% CI
Eribulin Mesylate6.54.5 – 12.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Eribulin Mesylate
Serious: 25/32 (78%)
Deaths: 0/32

Serious adverse events (41 terms)

ReactionSystemEribulin Mesylate
AnemiaBlood and lymphatic system disorders
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations
Abdominal PainGastrointestinal disorders
HematuriaRenal and urinary disorders
HyperglycemiaMetabolism and nutrition disorders
ParesthesiaNervous system disorders
Back painMusculoskeletal and connective tissue disorders
FatigueGeneral disorders
HeadacheNervous system disorders
HypotensionVascular disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Rectal hemorrhageGastrointestinal disorders
SepsisInfections and infestations
Thromboembolic eventVascular disorders
Urinary tract infectionInfections and infestations
AnorexiaMetabolism and nutrition disorders
Aspartate Aminotransferase increasedInvestigations
Bone painMusculoskeletal and connective tissue disorders
Cystitis noninfectiveRenal and urinary disorders
DehydrationMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders
DysphagiaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Febrile NeutropeniaBlood and lymphatic system disorders
Other adverse events (106 terms — click to expand)

ReactionSystemEribulin Mesylate
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
AlopeciaSkin and subcutaneous tissue disorders
AnorexiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
ParesthesiaNervous system disorders
VomitingGastrointestinal disorders
DizzinessNervous system disorders
Abdominal PainGastrointestinal disorders
Generalized weaknessMusculoskeletal and connective tissue disorders
Edema limbsGeneral disorders
Mucositis oralGastrointestinal disorders
White blood cell decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
Alkaline phosphatase increasedInvestigations
ChillsGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
Weight lossInvestigations
InsomniaPsychiatric disorders
DyspneaRespiratory, thoracic and mediastinal disorders
FeverGeneral disorders
HeadacheNervous system disorders
Neutrophil count decreasedInvestigations
Bone painMusculoskeletal and connective tissue disorders
DysgeusiaNervous system disorders
HyperglycemiaMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders
Rectal hemorrhageGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Aspartate Aminotransferase increasedInvestigations
Cystitis noninfectiveRenal and urinary disorders
Pelvic painReproductive system and breast disorders
Vaginal hemorrhageReproductive system and breast disorders
AnxietyPsychiatric disorders
DyspepsiaGastrointestinal disorders
HyponatremiaMetabolism and nutrition disorders

Most-reported serious reactions: Anemia, Neutrophil count decreased, White blood cell decreased, Abdominal Pain, Hematuria, Hyperglycemia, Paresthesia, Back pain.

Data from ClinicalTrials.gov NCT01676818 adverse events section.

Sponsor's own description

This phase II trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Eribulin in Cancer Treatment.
    Swami U, Shah U, Goel S. · · 2015 · cited 46× · PMID 26262627 · DOI 10.3390/md13085016

Verify or expand the search:

Other trials of eribulin mesylate

Trials testing the same drug.

Other recruiting trials for Recurrent Cervical Cancer

Currently open trials in the same condition.

Other University of Southern California trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01676818.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing