Trial Outcomes & Findings for A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors (NCT NCT04957290)

Last Updated: 2024-06-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Cycle 1 (Day 1 to Day 21)

Results posted on

2024-06-18

Participant Flow

21 patients

Participant milestones

Participant milestones
Measure	Part 1: Dose Cohort 1: NOX66 800 mg NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Overall Study STARTED	4	7	10
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	4	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Dose Cohort 1: NOX66 800 mg NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Overall Study Progressive disease	3	3	2
Overall Study Withdrawal by Subject	1	0	1
Overall Study Death	0	2	1
Overall Study non compliance with study drug	0	1	0
Overall Study none specified.	0	1	2
Overall Study unacceptable toxicity	0	0	1
Overall Study Adverse Event	0	0	1
Overall Study study terminated by sponsor	0	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 Participants NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 Participants NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 Participants NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.	Part 1: Dose Cohort 4: NOX66 2400 mg NOX66: NOX66 2400 mg daily (1200 mg suppository BID). 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.	Part 2: Arm 1: Patients With mCRPC (RP2D NOX66) NOX66: NOX66 RP2D 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.	Part 2: Arm 2: Patients With BC or NSCLC (RP2D NOX66) NOX66: NOX66 RP2D 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.	Total n=21 Participants Total of all reporting groups
Age, Continuous	69 years n=93 Participants	73 years n=4 Participants	67.5 years n=27 Participants	—	—	—	68 years n=115 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	—	—	—	5 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants	—	—	—	16 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	—	—	—	7 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants	—	—	—	14 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	—	—	—	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	3 Participants n=115 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants	—	—	—	17 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	—	—	—	0 Participants n=115 Participants
Region of Enrollment United States	4 participants n=93 Participants	6 participants n=4 Participants	8 participants n=27 Participants	—	—	—	18 participants n=115 Participants
Region of Enrollment Australia	0 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	—	—	—	1 participants n=115 Participants
Region of Enrollment Hungary	0 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	—	—	—	2 participants n=115 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Day 1 to Day 21)

Population: All patients that completed cycle 1.

Outcome measures

Outcome measures
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 Participants NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 Participants NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 Participants NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Part 1 (Dose Escalation): Number of Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Screening (Days -28 to -2) until the Follow-up visit/End of Study (EOS) (through study completion, an average of 19 month)

Population: Safety population = all participants who received at least one dose of NOX66

Characterization of the safety and tolerability of NOX66.

Outcome measures

Outcome measures
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 Participants NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 Participants NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 Participants NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Part 1: Incidence of Adverse Events (AEs) for NOX66 With at least one Adverse Event	4 Participants	7 Participants	9 Participants
Part 1: Incidence of Adverse Events (AEs) for NOX66 With at least one TEAE (Treatment Emergent Adverse Event)	4 Participants	7 Participants	9 Participants
Part 1: Incidence of Adverse Events (AEs) for NOX66 Dose Limiting Toxicity	0 Participants	0 Participants	0 Participants
Part 1: Incidence of Adverse Events (AEs) for NOX66 Fatal TEAE	0 Participants	1 Participants	0 Participants
Part 1: Incidence of Adverse Events (AEs) for NOX66 AEs that were greater than Grade 2 severity	1 Participants	5 Participants	5 Participants
Part 1: Incidence of Adverse Events (AEs) for NOX66 TEAE related to Study Treatment (NOX66)	4 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: From Screening (Days -28 to -2) until the Follow-up visit/EOS (through study completion, an average of 19 month)

Evaluation of the safety and tolerability of both doses of EBRT (8 Gy or 20/25 Gy).

Outcome measures

Outcome measures
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 Participants NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 Participants NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 Participants NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Part 1: TEAEs by Relationship to EBRT Administration Possibly Related	1 Participants	2 Participants	3 Participants
Part 1: TEAEs by Relationship to EBRT Administration Related	0 Participants	2 Participants	2 Participants
Part 1: TEAEs by Relationship to EBRT Administration No AEs related to EBRT	3 Participants	3 Participants	5 Participants

Adverse Events

Part 1: Dose Cohort 1: NOX66 800 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: Dose Cohort 2: NOX66 1200 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Part 1: Dose Cohort 3: NOX66 1600 mg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 participants at risk NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 participants at risk NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 participants at risk NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Nervous system disorders Encephalopathy	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Respiratory, thoracic and mediastinal disorders pleural effusion	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Gastrointestinal disorders diarrhea	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Cardiac disorders Angina pectoris	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
General disorders General physical health deterioration	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
General disorders Non-cardiac chest pain	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/10 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Psychiatric disorders Confusional state	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.

Other adverse events

Other adverse events
Measure	Part 1: Dose Cohort 1: NOX66 800 mg n=4 participants at risk NOX66: NOX66 800 mg daily (400 mg suppository twice daily \[BID\]). 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.	Part 1: Dose Cohort 2: NOX66 1200 mg n=7 participants at risk NOX66: NOX66 1200 mg daily (600 mg suppository BID). 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.	Part 1: Dose Cohort 3: NOX66 1600 mg n=10 participants at risk NOX66: NOX66 1600 mg daily (800 mg suppository BID). 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.
Gastrointestinal disorders Nausea	50.0% 2/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	40.0% 4/10 • Number of events 5 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Gastrointestinal disorders Anorectal discomfort	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Gastrointestinal disorders Proctitis	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Musculoskeletal and connective tissue disorders Back pain	50.0% 2/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	28.6% 2/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	30.0% 3/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Nervous system disorders Dizziness	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Nervous system disorders Headache	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	30.0% 3/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
General disorders Fatigue	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	28.6% 2/7 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Blood and lymphatic system disorders Lymphopenia	50.0% 2/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	14.3% 1/7 • Number of events 6 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	10.0% 1/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Psychiatric disorders Insomnia	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.
Renal and urinary disorders Proteinuria	0.00% 0/4 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	0.00% 0/7 • All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.	20.0% 2/10 • 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 at the time points specified in the Schedule of assessments with an average of 7 months for each participant.

Additional Information

Lorena, 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