Trial Outcomes & Findings for A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma (NCT NCT05100628)

Last Updated: 2025-01-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

Cycle 1 of each dose (Cycle length is 21 days)

Results posted on

2025-01-06

Participant Flow

Thirty patients were screened

Participant milestones

Participant milestones
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.
Overall Study STARTED	3	3	3
Overall Study COMPLETED	2	2	0
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin NOX66: 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. Doxorubicin: 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.
Overall Study Progressive Disease	1	0	0
Overall Study Study Terminated by Sponsor	0	0	3
Overall Study unkown	0	1	0

Baseline Characteristics

A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Total n=9 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 10.07 • n=5 Participants	52.0 years STANDARD_DEVIATION 7.81 • n=7 Participants	47.7 years STANDARD_DEVIATION 17.57 • n=5 Participants	51.3 years STANDARD_DEVIATION 10.11 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1 of each dose (Cycle length is 21 days)

Population: Patients that received at least one dose of NOX66

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.

Outcome measures

Outcome measures
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.
Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

Population: Patients treated with at least one dose of NOX66

Characterization of the safety and tolerability of NOX66.

Outcome measures

Outcome measures
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin n=3 Participants NOX66: 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. Doxorubicin: 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.
Number of Patients With Adverse Events (AEs) for NOX66 With at least one SAE	1 Participants	1 Participants	0 Participants
Number of Patients With Adverse Events (AEs) for NOX66 At least one TEAE possibly related to NOX66	3 Participants	2 Participants	1 Participants
Number of Patients With Adverse Events (AEs) for NOX66 With at least one Adverse Event	3 Participants	3 Participants	3 Participants
Number of Patients With Adverse Events (AEs) for NOX66 With at least one TEAE (Treatment Emergent Adverse Event)	3 Participants	3 Participants	3 Participants
Number of Patients With Adverse Events (AEs) for NOX66 At least one TEAE related to NOX66	0 Participants	0 Participants	1 Participants

Adverse Events

Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Infections and infestations Urosepsis	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 2 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Nervous system disorders Lethargy	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.

Other adverse events

Other adverse events
Measure	Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.	Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin n=3 participants at risk NOX66: 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. Doxorubicin: 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Gastrointestinal disorders Haemorrhoids	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	66.7% 2/3 • Number of events 2 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 2 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	66.7% 2/3 • Number of events 4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Infections and infestations COVID-19	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Investigations White blood cell count decreased	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Investigations Neutrophil count decreased	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 2 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.
Cardiac disorders Palpitations	0.00% 0/3 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.	33.3% 1/3 • Number of events 1 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug, an average of 14 months.

Additional Information

Lorena Figueroa, Director Clinical Operations

Noxopharm

Phone: + 61 2 9144 2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60