Metastatic Castration-resistant Prostate Cancer and Other Solid TumorsPhase 1/2NCT04957290
A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
A Phase 1/2 study testing NOX66 and EBRT in people with Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors, run by Noxopharm Limited at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
- What is being tested?
- NOX66 and EBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2021to 7 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beverly Hills Cancer Center
Beverly Hills, California, 90211
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
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).
Read the 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.
- Being tested
- NOX66, EBRT
- Keywords
- Dose Escalation, Dose Expansion, Prostate-specific antigen, Maximum tolerated dose, Recommended Phase 2 dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX66Drug
NOX66 800 mg daily (400 mg suppository twice daily [BID]).
NOX66Drug
NOX66 1200 mg daily (600 mg suppository BID).
NOX66Drug
NOX66 1600 mg daily (800 mg suppository BID).
NOX66Drug
NOX66 2400 mg daily (1200 mg suppository BID).
NOX66Drug
NOX66 RP2D
EBRTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Cohort 1: NOX66 800 mg | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
| Part 1: Dose Cohort 2: NOX66 1200 mg | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
| Part 1: Dose Cohort 3: NOX66 1600 mg | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
| Part 1: Dose Cohort 4: NOX66 2400 mg | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
| Part 2: Arm 1: Patients with mCRPC (RP2D NOX66) | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
| Part 2: Arm 2: Patients with BC or NSCLC (RP2D NOX66) | Experimental | Not described Receives: Drug: NOX66; Radiation: EBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (Dose Escalation): Number of Dose-limiting Toxicities (DLTs)
Maximum tolerated dose (MTD) and RP2D of NOX66 in combination with low-dose EBRT in patients with any solid tumor. MTD is defined as the dose level at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1. RP2D is the highest dose at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1 and the dosage form, is acceptable to patients.
A DLT is defined as an AE that occurs during Cycle 1 (Day 1 to Day 21) that is unrelated to the disease, intercurrent illness or concomitant medications and that, possibly- definitely related to NOX66 alone or in combination with EBRT:
Grade (G) ≥3 non-hematological toxicity; G≥3 febrile neutropenia; G4 thrombocytopenia > 5 days; G3 thrombocytopenia with bleeding or in combination with a G ≥3 blood and lymphatic system disorder.; G3 AST or ALT that is + a ≥G2 rise in bilirubin >7 days; AST or ALT > 8 × ULN; AE causing treatment delay > 14 days.
Measured: Cycle 1 (Day 1 to Day 21)
Secondary outcomes (2)
Part 1: Incidence of Adverse Events (AEs) for NOX66
Characterization of the safety and tolerability of NOX66.
Measured: From Screening (Days -28 to -2) until the Follow-up visit/End of Study (EOS) (through study completion, an average of 19 month)
Part 1: TEAEs by Relationship to EBRT Administration
Evaluation of the safety and tolerability of both doses of EBRT (8 Gy or 20/25 Gy).
Measured: From Screening (Days -28 to -2) until the Follow-up visit/EOS (through study completion, an average of 19 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start25 Oct 2021
- Primary completion10 May 2023
- Study completion7 Jun 2023
Why it stopped: Slow Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-resistant Prostate Cancer and Other Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noxopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957290
- Sponsor's protocol ID
- NOX66-005
- Status last verified
- May 2024
- First submitted
- 16 Jun 2021
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT04957290
- Acronym / sponsor ID
- NOX66-005
- Keywords
- Dose Escalation, Dose Expansion, Prostate-specific antigen, Maximum tolerated dose, Recommended Phase 2 dose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Noxopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Cohort 1: NOX66 800 mg | Experimental | Drug: NOX66, Radiation: EBRT |
| Part 1: Dose Cohort 2: NOX66 1200 mg | Experimental | Drug: NOX66, Radiation: EBRT |
| Part 1: Dose Cohort 3: NOX66 1600 mg | Experimental | Drug: NOX66, Radiation: EBRT |
| Part 1: Dose Cohort 4: NOX66 2400 mg | Experimental | Drug: NOX66, Radiation: EBRT |
| Part 2: Arm 1: Patients with mCRPC (RP2D NOX66) | Experimental | Drug: NOX66, Radiation: EBRT |
| Part 2: Arm 2: Patients with BC or NSCLC (RP2D NOX66) | Experimental | Drug: NOX66, Radiation: EBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOX66NOX66 800 mg daily (400 mg suppository twice daily [BID]). | Drug | Part 1: Dose Cohort 1: NOX66 800 mg |
| NOX66NOX66 1200 mg daily (600 mg suppository BID). | Drug | Part 1: Dose Cohort 2: NOX66 1200 mg |
| NOX66NOX66 1600 mg daily (800 mg suppository BID). | Drug | Part 1: Dose Cohort 3: NOX66 1600 mg |
| NOX66NOX66 2400 mg daily (1200 mg suppository BID). | Drug | Part 1: Dose Cohort 4: NOX66 2400 mg |
| NOX66NOX66 RP2D | Drug | Part 2: Arm 1: Patients with mCRPC (RP2D NOX66), Part 2: Arm 2: Patients with BC or NSCLC (RP2D NOX66) |
| EBRTThe 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. | Radiation | Part 1: Dose Cohort 1: NOX66 800 mg, Part 1: Dose Cohort 2: NOX66 1200 mg, Part 1: Dose Cohort 3: NOX66 1600 mg, Part 1: Dose Cohort 4: NOX66 2400 mg, Part 2: Arm 1: Patients with mCRPC (RP2D NOX66), Part 2: Arm 2: Patients with BC or NSCLC (RP2D NOX66) |
Primary outcome
Part 1 (Dose Escalation): Number of Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (Day 1 to Day 21)
Maximum tolerated dose (MTD) and RP2D of NOX66 in combination with low-dose EBRT in patients with any solid tumor. MTD is defined as the dose level at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1. RP2D is the highest dose at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1 and the dosage form, is acceptable to patients. A DLT is defined as an AE that occurs during Cycle 1 (Day 1 to Day 21) that is unrelated to the disease, intercurrent illness or concomitant medications and that, possibly- definitely related to NOX66 alone or in combination with EBRT: Grade (G) ≥3 non-hematological toxicity; G≥3 febrile neutropenia; G4 thrombocytopenia > 5 days; G3 thrombocytopenia with bleeding or in combination with a G ≥3 blood and lymphatic system disorder.; G3 AST or ALT that is + a ≥G2 rise in bilirubin >7 days; AST or ALT > 8 × ULN; AE causing treatment delay > 14 days.
2 secondary outcomes
Part 1: Incidence of Adverse Events (AEs) for NOX66
Time frame: From Screening (Days -28 to -2) until the Follow-up visit/End of Study (EOS) (through study completion, an average of 19 month)
Part 1: TEAEs by Relationship to EBRT Administration
Time frame: From Screening (Days -28 to -2) until the Follow-up visit/EOS (through study completion, an average of 19 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NOX66 and EBRT in people with Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors, run by Noxopharm Limited at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 (Dose Escalation): Number of Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (Day 1 to Day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.