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NCT05291286 · ClinicalTrials.gov registry record · Early Phase 1

BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients

A Early Phase 1 study of Chemotherapy-induced Peripheral Neuropathy and Neuropathy;Peripheral, sponsored by Bexion Pharmaceuticals.

Completed
Registry status
Early Phase 1
Development phase
21
Enrollment target
3
Study locations

NCT05291286 is a Early Phase 1 study of Chemotherapy-induced Peripheral Neuropathy and Neuropathy;Peripheral that has completed, run by Bexion Pharmaceuticals. The registered enrollment target is 21 participants, below the 138-participant average among 29 other Chemotherapy-induced Peripheral Neuropathy trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT05291286, a Early Phase 1 study of Chemotherapy-induced Peripheral Neuropathy and Neuropathy;Peripheral, has completed, sponsored by Bexion Pharmaceuticals.

COMPLETED
Registry status
Early Phase 1
Development phase
21 participants
Enrollment target
3
Study locations

Study Summary

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.

Conditions Studied

Chemotherapy-induced Peripheral Neuropathy Neuropathy;Peripheral

Interventions

  • OTHER Placebo
  • DRUG BXQ-350

Study Locations (3)

Ohio

  • CTI Clinical Research Center - Cincinnati
  • The Ohio State Unviersity - Columbus

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2022-10-17
Est. Completion 2024-12-20
Phase Early Phase 1

Sponsor

Bexion Pharmaceuticals

6 total trials

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What the Registry Record Tells You About NCT05291286

The ClinicalTrials.gov registry entry for NCT05291286 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 29 other Chemotherapy-induced Peripheral Neuropathy trials with a reported enrollment target (85% lower). The listed sponsor is Bexion Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Chemotherapy-induced Peripheral Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05291286 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Tennessee.

Frequently Asked Questions

What is clinical trial NCT05291286 about?

NCT05291286 is a clinical study titled "BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients". This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or ta...

What is the current status of trial NCT05291286?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2022-10-17. Estimated completion is 2024-12-20.

What conditions does trial NCT05291286 study?

This clinical trial studies the following conditions: Chemotherapy-induced Peripheral Neuropathy, Neuropathy;Peripheral.

What interventions are being tested in trial NCT05291286?

The interventions under investigation include: Placebo (OTHER), BXQ-350 (DRUG).

Who is sponsoring clinical trial NCT05291286?

This trial is sponsored by Bexion Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05291286 being conducted?

This trial has 3 study locations across Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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