NCT04957290

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

A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Noxopharm Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is divided into 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). The study design allows an exploration of different doses of NOX66 (800 mg, 1200 mg, 1600 mg and 2400 mg) with safety monitoring to ensure the safety of the patients. In Cycle 1, NOX66 will be administered for 14 days followed by a 7-day rest period on a 21-day cycle. From Cycle 2 onwards, NOX66 will be administered for 7 days followed by a 7-day rest period on a 14-day cycle. Patients will continue to receive NOX66 on a cyclical basis until disease progression, unacceptable toxicity, withdrawal of consent, start of a new anticancer therapy, withdrawal of the patient by the Investigator or the end of study is reached.

Conditions

• Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-25
• Primary completion: 2023-05-10
• Completion: 2023-06-07
• First posted: 2021-07-12
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study