Solid TumorsPhase 1NCT02680795
Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
A Phase 1 study testing Belinostat IV in people with Solid Tumors and Hematological Malignancies, run by Acrotech Biopharma Inc. at 3 sites in United States.
Trial summary
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematological Malignancies
- What is being tested?
- Belinostat IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2016to 21 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.
- Patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
- Patient has adequate hematological and hepatic functions.
Who cannot join
- Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.
- Patient has HBV or HCV
- Patient has a known HIV positive diagnosis.
- Patient has congestive heart failure Class III/IV
- Patient has had previous exposure to belinostat.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
John Wayne Cancer Institute @ Providence Saint John's Health Center
Santa Monica, California, 90404
The Oncology Institute of Hope and Innovation
Whittier, California, 90603
About this study
Official title: Open-label, Nonrandomized, Phase 1 Study Evaluating Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies in Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Read the detailed description
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Enrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.
- Conditions
- Solid Tumors, Hematological Malignancies
- Being tested
- Belinostat IV
- Keywords
- UGT1A1*28, Belinostat, beleodaq, wild type genotypes, heterozygous genotypes, homozygous genotypes
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belinostat IVDrug
Also called Beleodaq
Cohort A:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort B:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort C:
Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Wild Type UGT1A1 | Experimental | Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV Receives: Drug: Belinostat IV |
| Heterozygous UGT1A1*28 | Experimental | Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV Receives: Drug: Belinostat IV |
| Homozygous UGT1A1*28 | Experimental | Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV Receives: Drug: Belinostat IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine concentrations of belinostat will be measured
PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2)
Measured: 26 Weeks
Secondary outcomes (2)
Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03
Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes
Measured: 26 Weeks
Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing
Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start27 Apr 2016
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited, Axis Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Wasim Khan, MD, Study director, Acrotech Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680795
- Sponsor's protocol ID
- SPI-BEL-106
- Status last verified
- Oct 2025
- First submitted
- 9 Feb 2016
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Nonrandomized, Phase 1 Study Evaluating Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies in Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
- ClinicalTrials.gov ID
- NCT02680795
- Acronym / sponsor ID
- SPI-BEL-106
- Conditions
- Solid Tumors, Hematological Malignancies
- Keywords
- UGT1A1*28, Belinostat, beleodaq, wild type genotypes, heterozygous genotypes, homozygous genotypes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited, Axis Clinical Trials
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Detailed description
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Enrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wild Type UGT1A1 | Experimental | Drug: Belinostat IVCohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV |
| Heterozygous UGT1A1*28 | Experimental | Drug: Belinostat IVCohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV |
| Homozygous UGT1A1*28 | Experimental | Drug: Belinostat IVCohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.
- Patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
- Patient has adequate hematological and hepatic functions.
Key exclusion criteria (5 listed)
- Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.
- Patient has HBV or HCV
- Patient has a known HIV positive diagnosis.
- Patient has congestive heart failure Class III/IV
- Patient has had previous exposure to belinostat.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belinostat IVAlso: BeleodaqCohort A: Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion. Cohort B: Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion. Cohort C: Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion. | Drug | Heterozygous UGT1A1*28, Homozygous UGT1A1*28, Wild Type UGT1A1 |
Primary outcome
Plasma and urine concentrations of belinostat will be measured
Time frame: 26 Weeks
PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2)
2 secondary outcomes
Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03
Time frame: 26 Weeks
Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasim Khan, MD study director
Acrotech Biopharma Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belinostat IV in people with Solid Tumors and Hematological Malignancies, run by Acrotech Biopharma Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and urine concentrations of belinostat will be measured (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.