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NCT01613768

Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer

Completed Phase 2 Results posted Last updated 28 September 2018
What this trial tests

Phase 2 trial testing eribulin mesylate in Recurrent Salivary Gland Cancer in 29 participants. Completed in 23 August 2017.

Timeline
8 May 2012
Primary endpoint
23 August 2017
23 August 2017

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment29
Start date8 May 2012
Primary completion23 August 2017
Estimated completion23 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Recurrent Salivary Gland Cancer or Stage IVA Salivary Gland 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.

Response Rate Primary · From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, summarized using frequencies and percentages.

GroupValue95% CI
Treatment (Eribulin Mesylate)1
Treatment (Eribulin Mesylate)2
Treatment (Eribulin Mesylate)23
Treatment (Eribulin Mesylate)3
Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only) Secondary · From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, reported as median values.

GroupValue95% CI
Treatment (Eribulin Mesylate)33.724.0 – 77.9
Time to Progression Secondary · From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy.

Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), \> 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.

GroupValue95% CI
Treatment (Eribulin Mesylate)18.05.7 – 110.9
Disease Control Rate (DCR) Secondary · From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease Control Rate (D

GroupValue95% CI
Treatment (Eribulin Mesylate)26
Toxicity Rates Secondary · Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.

Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0

GroupValue95% CI
Treatment (Eribulin Mesylate)14

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Eribulin Mesylate)
Serious: 3/29 (10%)
Deaths: 0/29

Serious adverse events (3 terms)

ReactionSystemTreatment (Eribulin Mesyla…
Febrile neutropeniaBlood and lymphatic system disorders
Pathological spinal fractureMusculoskeletal and connective tissue disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Other adverse events (5 terms — click to expand)

ReactionSystemTreatment (Eribulin Mesyla…
Neutrophil count decreasedInvestigations
Peripheral sensory neuropathyNervous system disorders
FatigueGeneral disorders
MalaiseGeneral disorders
Creatinine increasedInvestigations

Most-reported serious reactions: Febrile neutropenia, Pathological spinal fracture, Epistaxis.

Data from ClinicalTrials.gov NCT01613768 adverse events section.

Sponsor's own description

Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in patients with salivary gland cancer. Researchers want to know if eribulin is safe and effective in treating salivary gland cancer.

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 Salivary Gland Cancer

Currently open trials in the same condition.

Other University of Washington 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/NCT01613768.

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