Clinical trial · Interventional
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
NCT01418677CI-TRIAL-00022214completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7389 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1
- interventionNames
- Drug: E7389
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2
- interventionNames
- Drug: E7389
- type
- ACTIVE_COMPARATOR
- label
- Cohort 3
- interventionNames
- Drug: E7389
Primary outcomes (1)
- measure
- To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). * Renal function must fall into one of the following categories: * Normal function - creatinine clearance greater than or equal to 80 mL/min. * Moderate impairment - creatinine clearance \>30 to 50 mL/min. * Severe impairment - creatinine clearance 15 to less than 30 mL/min. * Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times the ULN (in the case of liver metastasis less than or equal to 5 times ULN). In the case ALP \>3 times the ULN (in the absence of liver metastasis) or \>5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. Exclusion Criteria: * Subjects with mild renal impairment (creatinine clearance greater than 50 to less than 80 mL/min). * Subjects with end stage renal disease (creatinine clearance less than 15 mL/min or on dialysis). * Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives. * Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment. * Radiation therapy encompassing \>30 % of bone marrow. * Subjects with organ allografts requiring immunosuppression.
References
Publications (1)
- DERIVEDTan AR, Sarantopoulos J, Lee L, Reyderman L, He Y, Olivo M, Goel S. Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function. Cancer Chemother Pharmacol. 2015 Nov;76(5):1051-61. doi: 10.1007/s00280-015-2878-5. Epub 2015 Oct 3. PMID 26433580