Phase 1
Completed N=12
Evaluating the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (Bolus) Infusion of Eribulin in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT01000376 ↗Enrolled (actual)
12
Serious AEs
22.7%
Results posted
Sep 2013
Primary outcomePrimary: Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin — 207; 106 ng*mL
Summary
The purpose of this study is to investigate whether ketoconazole, taken orally, influences the level of eribulin in the blood when the two drugs are given at the same time. The study will enroll patients with solid tumors whose cancer became worse even after standard treatment, or for whom there is no standard treatment available. The study will also investigate whether eribulin given together with ketoconazole is safe (has few side-effects) and is effective against cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin |
207; 106 | — |
| PRIMARY Mean (SD) Area Under Concentration Time Curve From Zero to Infinity (AUC 0-oo) of Eribulin |
971; 482 | — |
| SECONDARY Safety of Eribulin Administered Alone or Coadministered With Oral Ketoconazole, as Measured by Number of Subjects With Adverse Events. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
- Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
- Patients must be aged ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Life expectancy of ≥ 3 months.
- Patients must have adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL (≤ 176 mol/L) or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.
- Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times the upper limit of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 times the ULN, (in the case of liver metastases ≤ 5 times ULN or in the case of bone metastases, the liver specific alkaline phosphatase ≤ 3 times ULN).
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, hemoglobin ≥ 10.0 g/dL or ≥ 6.2 mmol/L (a hemoglobin New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia.
- Patients with organ allografts requiring immunosuppression (not including blood and blood components transfusions).
- Patients with known positive human immunodeficiency virus (HIV) status.
- Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with eribulin.
- Patients with meningeal carcinomatosis.
- Patients with a hypersensitivity to halichondrin B and/or halichondrin B-like compounds.
- Patients with pre-existing neuropathy > Grade 2.
- Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
Data sourced from ClinicalTrials.gov (NCT01000376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.