- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583777
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Belinostat in Patients With Advanced Cancer
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28050
- Hospital Universitario Madrid Sanchinarro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent document indicating understanding of the purpose of and procedures required for the study and willingness to participate in the study.
- Histological confirmation of cancer and refractory or intolerant to standard therapy or cancer for which no standard therapy exists.
- Age at study entry of 18 years or older.
- Availability to stay in the research unit for the first 7 days.
- Adequate renal function defined as a calculated creatinine clearance (CrCl) of > 45 mL/minute.
- Adequate hepatic function: total bilirubin < 1.5 x the upper limits of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN.
- Adequate hematopoietic function defined as an absolute neutrophil count (ANC) > 1000 cells/µL and platelet count > 50,000/µL.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- If female, patient must be postmenopausal for at least 1 year, documented surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or of childbearing potential and practicing birth control. Acceptable contraceptive methods in this study are intrauterine device; diaphragm or condom in combination with spermicidal foam or jelly; injectable, implantable, or transdermal patch; or oral contraception.
- Female patients must have a negative pregnancy test at the Screening Visit and at the end of study treatment (30 days after the last dose of belinostat).
Exclusion Criteria:
- Known anal or urinary incontinence.
- Diagnosis of acute myelogenous leukemia (AML), multiple myeloma, primary hepatic or renal carcinomas.
- Inability to consume oral fluids.
- Treatment with drugs known to inhibit metabolic pathways (glucuronidation, CYP system) in the 4 weeks before the Screening Visit.
- Concurrent treatment with diuretics or laxatives.
- Radiotherapy involving mouth, esophagus, and gastrointestinal tract in the 4 weeks before the Screening Visit.
- Polymorphism in UGT1A1.
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or C.
- Previous participation in a study utilizing 14C.
- Body surface area < 1.5 m2.
- Ongoing or medical history of a physical or psychiatric illness, significant comorbidity, or any medical disorder other than cancer that may require treatment or make the subject unlikely to fully complete the study.
- Use of another investigational product or anticancer agent within 4 weeks prior to the Screening Visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Belinostat
Open Label
|
On Day 1, a single dose of 14C-labeled belinostat (approximately 94 to 105 µCi, 1500 mg) will be administered to the patient as a 30-minute IV infusion. After Cycle 1 evaluations are completed, and if it is in the best interest of the patient, patients may receive additional cycles of non-radiolabeled belinostat until disease progression, unacceptable toxicity, or initiation of new anticancer therapy. After Cycle 1, Day 21, non radiolabeled belinostat will be administered IV as a 30 -45 minute infusion of 1000 mg/m2 on Days 1 through 5 every 21 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum recovery of the radioactive dose in urine and feces
Time Frame: 6 months
|
The route of elimination of belinostat will be determined by the recovery of total radioactivity (parent drug and metabolites) and unmetabolized belinostat in urine and feces following single IV administration of 14C-labeled belinostat in patients with recurrent or progressive malignancy.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Concentration of Belinostat in plasma, urine, and feces and its metabolites
Time Frame: 6 months
|
Secondary objectives are to determine the PK of 14C-labeled belinostat in plasma, urine, and feces following IV administration; to determine the relative proportion of 14C-labeled belinostat and its radiolabeled metabolites in plasma, urine, and feces; and to assess the safety of belinostat.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mi R Choi, MD, Spectrum Pharmaceuticals, Inc
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPI-BEL-12-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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