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A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
Phase 1 trial testing Eribulin Mesylate in Metastatic Urothelial Cell Cancer in 6 participants. Terminated before completion.
| Lead sponsor | Monika Joshi, MD |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 12 June 2018 |
| Primary completion | 25 October 2019 |
| Estimated completion | 25 October 2019 |
| Sites | 2 locations across United States |
Monika Joshi, MD
18 and older, any sex, with Metastatic Urothelial Cell Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose limiting toxicities (DLTs) experienced by subjects while being treated with the combination of eribulin+avelumab, by dose level.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 0: Starting Cohort | 0 | |
| Dose Level 1 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 0: Starting Cohort | 0 | |
| Dose Level 1 | 1 |
Time frame: Up to six cycles (6 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Subjects |
|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | — |
| FEVER | General disorders | — |
| INFECTIONS AND INFESTATIONS | Infections and infestations | — |
| URINARY TRACT INFECTION | Infections and infestations | — |
| Reaction | System | All Subjects |
|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | — |
| CHILLS | General disorders | — |
| CREATININE INCREASED | Investigations | — |
| LYMPHOCYTE COUNT DECREASED | Investigations | — |
| NEUTROPHIL COUNT DECREASED | Investigations | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — |
| ALOPECIA | Skin and subcutaneous tissue disorders | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — |
| FATIGUE | General disorders | — |
| INFUSION RELATED REACTION | General disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| WHITE BLOOD CELL DECREASED | Investigations | — |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | — |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| BUTTOCK PAIN | Musculoskeletal and connective tissue disorders | — |
| DIARRHEA | Gastrointestinal disorders | — |
| DYSGEUSIA | Nervous system disorders | — |
| EDEMA LIMBS | General disorders | — |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | — |
| HEADACHE | Nervous system disorders | — |
| HEMATURIA | Renal and urinary disorders | — |
| HYPERKALEMIA | Metabolism and nutrition disorders | — |
| HYPONATREMIA | Metabolism and nutrition disorders | — |
| HYPOTHYROIDISM | Endocrine disorders | — |
| INFECTIONS AND INFESTATIONS | Infections and infestations | — |
| INFUSION SITE EXTRAVASATION | General disorders | — |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Injury, poisoning and procedural complications | — |
| KIDNEY INFECTION | Infections and infestations | — |
| LIPASE INCREASED | Investigations | — |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER | Musculoskeletal and connective tissue disorders | — |
| MYALGIA | Musculoskeletal and connective tissue disorders | — |
| NAIL INFECTION | Infections and infestations | — |
| PARESTHESIA | Nervous system disorders | — |
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | — |
| RASH ACNEIFORM | Skin and subcutaneous tissue disorders | — |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | — |
| SERUM AMYLASE INCREASED | Investigations | — |
| SINUS PAIN | Nervous system disorders | — |
Most-reported serious reactions: FEBRILE NEUTROPENIA, FEVER, INFECTIONS AND INFESTATIONS, URINARY TRACT INFECTION.
Data from ClinicalTrials.gov NCT03502681 adverse events section.
This is a single arm, open-label phase Ib study of combining eribulin mesylate with avelumab. The initial 9-12 patients (MTD cohort) will be enrolled to determine safety of avelumab in combination with eribulin mesylate. Upon determination of maximum tolerated dose (MTD), 12 additional patients will be enrolled in an expansion cohort (efficacy cohort) to determine ORR at 6 months.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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