← Back to Search

Belinostat & Atazanavir for Blood Cancers

Phase 1
Waitlist Available
Research Sponsored by Acrotech Biopharma LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 (±5) days after the last dose of belinostat
Awards & highlights

Study Summary

This trial is for patients who have already completed a belinostat study and want to continue receiving treatment. The extension is optional and voluntary.

Eligible Conditions
  • Blood Cancers
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 (±5) days after the last dose of belinostat
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 (±5) days after the last dose of belinostat for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment

Trial Design

4Treatment groups
Experimental Treatment
Group I: Wild Type UGT1A1Experimental Treatment1 Intervention
Cohort A: Wild Type, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
Group II: Homozygous UGT1A1*28Experimental Treatment1 Intervention
Cohort C: Homozygous, UGT1A1, Belinostat IV Dose: 750 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
Group III: Heterozygous UGT1A1*28Experimental Treatment1 Intervention
Cohort B: Heterozygous, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
Group IV: Belinostat & AtazanavirExperimental Treatment2 Interventions
Arm: Homozygous UGT1A1*28 genotype subjects with Belinostat IV & Atazanavir Dose: 750mg/ m2 (Belinostat IV), 400mg (Atazanavir) Frequency: two cycles of 21 days (Belinostat administered through Cycle 2, Day 5) Atazanavir 400mg administered Cycle 1 Day 15 to Day 21, and Cycle 2 Day 1 to Day 5 Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atazanavir
FDA approved
Belinostat
FDA approved

Find a Location

Who is running the clinical trial?

Acrotech Biopharma LLCLead Sponsor
27 Previous Clinical Trials
3,831 Total Patients Enrolled
Axis Clinicals LimitedIndustry Sponsor
7 Previous Clinical Trials
332 Total Patients Enrolled
Acrotech Biopharma Inc.Lead Sponsor
30 Previous Clinical Trials
5,171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
2019. "Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04184869.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top