Metastatic Soft-tissue SarcomaPhase 1NCT05100628
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
A Phase 1 study testing NOX66 and Doxorubicin in people with Metastatic Soft-tissue Sarcoma, run by Noxopharm Limited at 4 sites in United States.
Trial summary
This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Soft-tissue Sarcoma
- What is being tested?
- NOX66 and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Feb 2022to 26 May 2023
- Phase
- Phase 1
- 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
- Adult patients with a histologically confirmed diagnosis of metastatic or recurrent soft tissue sarcoma
- Patients for whom treatment with doxorubicin is considered to be appropriate
- Left ventricular ejection fraction ≥ 50%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Disease that is considered measurable according to RECIST v1.1.
Who cannot join
- Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma, and desmoid tumor
- Untreated metastases to the central nervous system
- Received previous treatment with anthracyclines and anthracenediones
- Previous radiation therapy to the mediastinal or pericardial area
- A known allergy to any of the treatment components
- Patient not willing to use suppositories
Show all 14Show fewer
- Patients with a colostomy
- 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 (e.g., inflamed hemorrhoids, fissures, or lesions of the anus or rectum)
- Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or alternating irritable bowel disease
- Patients with inflammatory bowel disease
- Previous treatment with an investigational agent or the non-approved use of a drug or device within 4 weeks before study entry
- Uncontrolled diabetes mellitus
- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P- glycoprotein (P- gp)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope
Duarte, California, 91010
Mayo Clinic Florida - Oncology
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
Site name Washington University School of Medicine in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2
This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.
Read the detailed description
The study will contain dose-escalation cohorts and dose-expansion cohorts. The study design allows an exploration of different doses of NOX66 with safety monitoring to ensure the safety of the patients.
Dose-escalation cohorts: It will include three planned Treatment Groups (800, 1200, 1800 mg daily) and patients enrolled in these groups will receive 7 days of monotherapy treatment with NOX66 followed by a 5-day washout period. Thereafter, patients will enter a combination therapy (only if no significant toxicity is observed during monotherapy). This will commence with Cycle 1, which will consist of 7 days of NOX66, and on Day 2 of the 21-day cycle, doxorubicin will be administered. Patients will continue to be treated for up to 6 x 21-day cycles of NOX66 and doxorubicin. New patients will be entered at the next dose level of NOX66, if no dose-limiting toxicities have occurred among the first 3 patients at the end of cycle 1. During the dose-escalation, MTD of the combination of NOX66 and doxorubicin will be determined.
Dose-expansion cohort: On completion of the dose-escalation cohort, patients will be enrolled into a dose-expansion at the MTD of the combination of NOX66 and doxorubicin. All patients will enter directly into 21-day combination cycles and will be given NOX66 therapy for 7 days and doxorubicin will be administered on Day 2 of each cycle. Treatment will be terminated upon disease progression, unacceptable toxicity, or a maximum of 6 cycles.
- Conditions
- Metastatic Soft-tissue Sarcoma
- Being tested
- NOX66, Doxorubicin
- Keywords
- Doxorubicin, Dose-escalation study, Dose-expansion study, Maximum tolerated dose
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX66Drug
NOX66 800 mg (400 mg suppository twice daily [BID]).
Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles.
NOX66Drug
NOX66 1200 mg daily (600 mg suppository BID).
Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles.
NOX66Drug
NOX66 1800 mg daily (600 mg suppository thrice daily).
Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles.
NOX66Drug
MTD of the combination of NOX66 and doxorubicin will be determined in the dose-escalation cohort of the study. The selected dose will be administered in combination with Doxorubicin.
DoxorubicinDrug
Doxorubicin will be given at 75 mg/m^2 as an intravenous infusion on Day 2 of the 21-day cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin | Experimental | Not described Receives: Drug: NOX66; Drug: Doxorubicin |
| Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin | Experimental | Not described Receives: Drug: NOX66; Drug: Doxorubicin |
| Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin | Experimental | Not described Receives: Drug: NOX66; Drug: Doxorubicin |
| Dose-Expansion Cohort: NOX66 + Doxorubicin | Experimental | Not described Receives: Drug: NOX66; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs)
Determination of the MTD of NOX66 in combination with doxorubicin. MTD is defined as the dose level at which no more than 1 patient out of 6 experiences a DLT at the end of Cycle 1.
Measured: Cycle 1 of each dose (Cycle length is 21 days)
Number of Patients With Adverse Events (AEs) for NOX66
Characterization of the safety and tolerability of NOX66.
Measured: From first study treatment with DOX66 monotherapy through study completion, approximately of 14 months and 20 days. From February 11, 2022, to May 1, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start11 Feb 2022
- Primary completion1 May 2023
- Study completion26 May 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 Soft-tissue SarcomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05100628
- Sponsor's protocol ID
- NOX66-004
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2021
- Last updated
- 6 Jan 2025
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2
- ClinicalTrials.gov ID
- NCT05100628
- Acronym / sponsor ID
- NOX66-004
- Conditions
- Metastatic Soft-tissue Sarcoma
- Keywords
- Doxorubicin, Dose-escalation study, Dose-expansion study, Maximum tolerated dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Noxopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Posted 6 Jan 2025
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 I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.
Detailed description
The study will contain dose-escalation cohorts and dose-expansion cohorts. The study design allows an exploration of different doses of NOX66 with safety monitoring to ensure the safety of the patients.
Dose-escalation cohorts: It will include three planned Treatment Groups (800, 1200, 1800 mg daily) and patients enrolled in these groups will receive 7 days of monotherapy treatment with NOX66 followed by a 5-day washout period. Thereafter, patients will enter a combination therapy (only if no significant toxicity is observed during monotherapy). This will commence with Cycle 1, which will consist of 7 days of NOX66, and on Day 2 of the 21-day cycle, doxorubicin will be administered. Patients will continue to be treated for up to 6 x 21-day cycles of NOX66 and doxorubicin. New patients will be entered at the next dose level of NOX66, if no dose-limiting toxicities have occurred among the first 3 patients at the end of cycle 1. During the dose-escalation, MTD of the combination of NOX66 and doxorubicin will be determined.
Dose-expansion cohort: On completion of the dose-escalation cohort, patients will be enrolled into a dose-expansion at the MTD of the combination of NOX66 and doxorubicin. All patients will enter directly into 21-day combination cycles and will be given NOX66 therapy for 7 days and doxorubicin will be administered on Day 2 of each cycle. Treatment will be terminated upon disease progression, unacceptable toxicity, or a maximum of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin | Experimental | Drug: NOX66, Drug: Doxorubicin |
| Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin | Experimental | Drug: NOX66, Drug: Doxorubicin |
| Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin | Experimental | Drug: NOX66, Drug: Doxorubicin |
| Dose-Expansion Cohort: NOX66 + Doxorubicin | Experimental | Drug: NOX66, Drug: Doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with a histologically confirmed diagnosis of metastatic or recurrent soft tissue sarcoma
- Patients for whom treatment with doxorubicin is considered to be appropriate
- Left ventricular ejection fraction ≥ 50%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Disease that is considered measurable according to RECIST v1.1.
Key exclusion criteria (14 listed)
- Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma, and desmoid tumor
- Untreated metastases to the central nervous system
- Received previous treatment with anthracyclines and anthracenediones
- Previous radiation therapy to the mediastinal or pericardial area
- A known allergy to any of the treatment components
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 (400 mg suppository twice daily [BID]). Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles. | Drug | Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin |
| NOX66NOX66 1200 mg daily (600 mg suppository BID). Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles. | Drug | Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin |
| NOX66NOX66 1800 mg daily (600 mg suppository thrice daily). Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles. | Drug | Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin |
| NOX66MTD of the combination of NOX66 and doxorubicin will be determined in the dose-escalation cohort of the study. The selected dose will be administered in combination with Doxorubicin. | Drug | Dose-Expansion Cohort: NOX66 + Doxorubicin |
| DoxorubicinDoxorubicin will be given at 75 mg/m^2 as an intravenous infusion on Day 2 of the 21-day cycle for up to 6 cycles. | Drug | Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin, Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin, Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin, Dose-Expansion Cohort: NOX66 + Doxorubicin |
Primary outcome
Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 of each dose (Cycle length is 21 days)
Determination of the MTD of NOX66 in combination with doxorubicin. MTD is defined as the dose level at which no more than 1 patient out of 6 experiences a DLT at the end of Cycle 1.
Number of Patients With Adverse Events (AEs) for NOX66
Time frame: From first study treatment with DOX66 monotherapy through study completion, approximately of 14 months and 20 days. From February 11, 2022, to May 1, 2023
Characterization of the safety and tolerability of NOX66.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOX66 and Doxorubicin in people with Metastatic Soft-tissue Sarcoma, run by Noxopharm Limited at 4 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 5 inclusion and 14 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
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 6 Jan 2025). 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?
Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 of each dose (Cycle length is 21 days)). The study lists 2 primary outcomes in all. 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 6 Jan 2025.