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

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

In brief

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).

Key facts

Study ID: NCT04957290
Run by: Noxopharm Limited
People needed: 21
Starts: 2021-10-25
Expected to finish: 2023-06-07
Last updated by the study team: 2024-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient has a minimum life expectancy of 6 months
Histological or cytological confirmation of prostate cancer, BC, NSCLC and any other solid tumors
Confirmed metastatic disease by imaging
Documented disease progression following first or later lines of anticancer systemic treatment
Patient is eligible for low-dose EBRT for at least one lesion
Patients with prior RT are eligible, only if there is no potential for field overlap between the prior RT and the planned RT
For patients with BC or NSCLC: Patient must have at least one measurable lesion as per RECIST v1.1 (in Part 2 only)
Patient has ECOG performance status of 0 to 2
Adequate bone marrow, renal, and liver function
Metastatic Castration-resistant Prostate Cancer: Baseline testosterone levels ≤ 14.4 ng/dL and ongoing medical castration must be maintained throughout the duration of the study; patient has evidence of symptomatic and/or progressive disease
Breast Cancer Patients: Known hormone receptor status (estrogen receptors/progesterone receptors or estrogen receptors alone). Breast cancer patients are allowed to be on background hormonal treatment.

You may not qualify if…

Patient has tumor involvement of the central nervous system
Impaired cardiac functioning or clinically significant cardiac disease
Uncontrolled hypertension despite two concomitant antihypertensive therapies
Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis
Patients for whom administration of the suppositories are likely to cause pain or difficulties in absorption
Patients with fecal impaction or uncontrolled irritable bowel disease
Patients with inflammatory bowel disease
Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that, in the Investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent
Patients with oligometastatic disease (fewer than 5 metastatic lesions) amenable to standard therapy will be excluded
Patients who have had RT to the region of the rectum or will require RT to the region of the rectum during the trial
Uncontrolled active infection requiring intravenous antibiotic, antiviral or anti-fungal medications within 14 days before the first dose administration
Receiving or having received anticancer treatment
Patient has received corticosteroids at a dose of > 10 mg prednisone/day or equivalent for any reason within 4 weeks prior to receiving the first dose administration
Patient is not willing to use suppositories
Patient has a positive reverse transcription polymerase chain reaction (RT-PCR) test for severe acute respiratory coronavirus 2 (SARS-CoV-2) prior to Screening or enrollment, or has clinical signs and symptoms consistent with SARS-CoV-2 infection; e.g., fever, dry cough, dyspnea, sore throat, fatigue or positive SARS-CoV-2 test result within 2 weeks prior to Screening.

Where it is running

Beverly Hills Cancer Center — Beverly Hills, California, United States
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.