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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583777
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : January 3, 2020
Information provided by (Responsible Party):
Acrotech Biopharma LLC

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date January 3, 2020
Study Start Date  ICMJE September 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
Official Title  ICMJE A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Belinostat in Patients With Advanced Cancer
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.
Detailed Description This is a Phase 1, open-label, single-dose study of 14C-labeled belinostat to determine routes of elimination of belinostat. A single dose of 14C-labeled belinostat (approximately 94.3 to 105 µCi, 1500 mg) will be administered as a 30-minute IV infusion to the patient. Routes of elimination of belinostat and its metabolites will be assessed by estimating the recovery of total radioactivity and parent belinostat over a period of 7 days. Plasma samples will be taken for 3 days at specified intervals for PK assessments. Total radioactivity in plasma, urine, and feces will be determined by liquid scintillation counting. Concentrations of belinostat in plasma and urine will be determined using a validated liquid chromatography - tandem mass spectroscopy (LC-MS/MS) method. Selected plasma, urine, and feces samples will be retained for use in the metabolism investigation. Samples will be initially analyzed using radio-high performance liquid chromatography (HPLC) to determine the number and relative proportion of belinostat and metabolites present. Selected samples will be subsequently analyzed using LC-MS to identify the major metabolites (> 10% of parent area under the curve [AUC]). If it is in the interest of the patient, treatment with non-radiolabeled belinostat may be continued with 21-day cycles until disease progression, initiation of new anticancer therapy, or an adverse event (AE) that may affect patient participation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: Belinostat

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 Name: beleodaq
Study Arms  ICMJE Experimental: Belinostat
Open Label
Intervention: Drug: Belinostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2012)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent document indicating understanding of the purpose of and procedures required for the study and willingness to participate in the study.
  2. Histological confirmation of cancer and refractory or intolerant to standard therapy or cancer for which no standard therapy exists.
  3. Age at study entry of 18 years or older.
  4. Availability to stay in the research unit for the first 7 days.
  5. Adequate renal function defined as a calculated creatinine clearance (CrCl) of > 45 mL/minute.
  6. 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.
  7. Adequate hematopoietic function defined as an absolute neutrophil count (ANC) > 1000 cells/µL and platelet count > 50,000/µL.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. Life expectancy of at least 12 weeks.
  10. 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.
  11. 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:

  1. Known anal or urinary incontinence.
  2. Diagnosis of acute myelogenous leukemia (AML), multiple myeloma, primary hepatic or renal carcinomas.
  3. Inability to consume oral fluids.
  4. Treatment with drugs known to inhibit metabolic pathways (glucuronidation, CYP system) in the 4 weeks before the Screening Visit.
  5. Concurrent treatment with diuretics or laxatives.
  6. Radiotherapy involving mouth, esophagus, and gastrointestinal tract in the 4 weeks before the Screening Visit.
  7. Polymorphism in UGT1A1.
  8. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or C.
  9. Previous participation in a study utilizing 14C.
  10. Body surface area < 1.5 m2.
  11. 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.
  12. Use of another investigational product or anticancer agent within 4 weeks prior to the Screening Visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01583777
Other Study ID Numbers  ICMJE SPI-BEL-12-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acrotech Biopharma LLC
Study Sponsor  ICMJE Acrotech Biopharma LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mi R Choi, MD Spectrum Pharmaceuticals, Inc
PRS Account Acrotech Biopharma LLC
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP