Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer

NCT01583777 | Completed Phase 1

• 1 other identifier: SPI-BEL-12-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy.

Conditions

Advanced Cancer

Keywords

Belinostat

Outcome Measures

Primary Outcomes (1)

• Maximum recovery of the radioactive dose in urine and feces

  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 Outcomes (1)

• The Concentration of Belinostat in plasma, urine, and feces and its metabolites

  6 months

Study Arms (1)

Belinostat

EXPERIMENTAL

Open Label

Drug: Belinostat

Interventions

Belinostat DRUG

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.

Also known as: beleodaq

Belinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

Study Sites (1)

Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Interventions

belinostat

Study Officials

• Mi R Choi, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 24, 2012
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

ES (1)