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A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

NCT04957290 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-06-18

Study results available
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Summary

This is a Phase 1b/Phase 2a, open-label, multicenter study to determine the safety, tolerability, recommended Phase 2 dose (RP2D), efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) properties of idronoxil when rectally administered as a suppository (NOX66) to patients with any solid tumor (Part 1) and patients with metastatic castration-resistant prostate cancer (mCRPC), breast cancer (BC) and non-small-cell lung cancer (NSCLC) (Part 2) who are eligible for low-dose external beam radiotherapy (EBRT) for at least one symptomatic or minimally symptomatic lesion (for the prevention of symptoms).

Conditions

  • Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Interventions

DRUG

NOX66

NOX66 800 mg daily (400 mg suppository twice daily \[BID\]).

DRUG

NOX66

NOX66 1200 mg daily (600 mg suppository BID).

DRUG

NOX66

NOX66 1600 mg daily (800 mg suppository BID).

DRUG

NOX66

NOX66 2400 mg daily (1200 mg suppository BID).

DRUG

NOX66

NOX66 RP2D

RADIATION

EBRT

The dose levels of EBRT will be either 8 Gy as a single fraction, or 20/25 Gy as 5 fractions given over 5 to 10 days.

Sponsors & Collaborators

  • Noxopharm Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2023-05-10
Completion
2023-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957290 on ClinicalTrials.gov