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Gene-Based dosing study aims to make cancer drug safer

NCT ID NCT02680795

Knowledge-focused Sponsor: Acrotech Biopharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested the safety and drug levels of belinostat in 17 patients with advanced solid tumors or blood cancers that had not responded to prior treatments. Researchers grouped patients by their UGT1A1 gene type to see if genetic differences affect how the drug is processed. The goal was to gather information for safer dosing in future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belinostat (Beleodaq)
What this could lead to
If successful, this study could help doctors understand how to dose belinostat more safely for patients with different genetic backgrounds.
What could go wrong
This is a very early, small study with only 17 participants, so results may not apply to all patients. The drug may still cause side effects regardless of gene type.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Apr 2016

Finished

Jul 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists. 2. 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. 3. Patient has adequate hematological and hepatic functions. Exclusion Criteria: 1. Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening. 2. Patient has HBV or HCV 3. Patient has a known HIV positive diagnosis. 4. Patient has congestive heart failure Class III/IV 5. Patient has had previous exposure to belinostat.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematological malignancies Solid tumors

Contacts and locations

Locations

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • John Wayne Cancer Institute @ Providence Saint John's Health Center

    Santa Monica, California, 90404, United States

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603, United States

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