Trial Outcomes & Findings for A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer (NCT NCT03735680)

Last Updated: 2023-07-07

Results Overview

Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma \[NSCLC\]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value \[PPV\] of ONM-100 for intraoperative imaging during HNSCC surgery.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

1 day

Results posted on

2023-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1, Cohort A Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.	Part 1, Cohort B Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose.	Part 1, Cohort E Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg.	Part 2, Group 2 Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg. Surgery/imaging time hours to be determined (TBD).	Part 2, Group 3 Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg. Surgery/imaging time, hours 16-80.	Part 3 Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery.
Overall Study STARTED	3	3	3	4	6	11
Overall Study COMPLETED	3	2	2	4	6	10
Overall Study NOT COMPLETED	0	1	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1, Cohort A Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.	Part 1, Cohort B Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose.	Part 1, Cohort E Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg.	Part 2, Group 2 Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg. Surgery/imaging time hours to be determined (TBD).	Part 2, Group 3 Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg. Surgery/imaging time, hours 16-80.	Part 3 Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery.
Overall Study Withdrawal by Subject	0	1	0	0	0	1
Overall Study Patient unable or unwilling to continue	0	0	1	0	0	0

Baseline Characteristics

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, Cohort A n=3 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.	Part 1, Cohort B n=3 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 3.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.	Part 1, Cohort E n=3 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 2 mg/kg and underwent surgery and fluorescence imaging at 6 ±3 hours post dose.	Part 2, Group 2 n=4 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg and underwent surgery and fluorescence imaging at a time to be determined post dose.	Part 2, Group 3 n=6 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 16-80 hours post dose.	Part 3 n=11 Participants Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 24 ±8 hours post dose.	Total n=30 Participants Total of all reporting groups
Age, Continuous	56.0 years STANDARD_DEVIATION 8.19 • n=39 Participants	63.7 years STANDARD_DEVIATION 3.79 • n=41 Participants	59.3 years STANDARD_DEVIATION 15.31 • n=35 Participants	65.5 years STANDARD_DEVIATION 5.07 • n=31 Participants	59.8 years STANDARD_DEVIATION 4.71 • n=146 Participants	59.8 years STANDARD_DEVIATION 10.26 • n=19 Participants	60.5 years STANDARD_DEVIATION 8.46 • n=147 Participants
Sex: Female, Male Female	2 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=31 Participants	0 Participants n=146 Participants	3 Participants n=19 Participants	8 Participants n=147 Participants
Sex: Female, Male Male	1 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants	3 Participants n=31 Participants	6 Participants n=146 Participants	8 Participants n=19 Participants	22 Participants n=147 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	3 Participants n=147 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=39 Participants	2 Participants n=41 Participants	3 Participants n=35 Participants	4 Participants n=31 Participants	5 Participants n=146 Participants	10 Participants n=19 Participants	25 Participants n=147 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	1 Participants n=19 Participants	2 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	1 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	1 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	2 Participants n=19 Participants	5 Participants n=147 Participants
Race (NIH/OMB) White	3 Participants n=39 Participants	3 Participants n=41 Participants	1 Participants n=35 Participants	3 Participants n=31 Participants	5 Participants n=146 Participants	7 Participants n=19 Participants	22 Participants n=147 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	2 Participants n=19 Participants	2 Participants n=147 Participants
Region of Enrollment United States	3 participants n=39 Participants	3 participants n=41 Participants	3 participants n=35 Participants	4 participants n=31 Participants	6 participants n=146 Participants	11 participants n=19 Participants	30 participants n=147 Participants
Patients receiving pegsitacianine (ONM-100)	3 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants	4 Participants n=31 Participants	6 Participants n=146 Participants	11 Participants n=19 Participants	30 Participants n=147 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=1 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 n=4 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 n=6 Participants All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 n=11 Participants All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]	1.098 ratio Standard Deviation 0	4.022 ratio Standard Deviation 2.8139	2.280 ratio Standard Deviation 1.6393	4.110 ratio Standard Deviation 1.2527	3.007 ratio Standard Deviation 1.3822	2.608 ratio Standard Deviation 2.5936

PRIMARY outcome

Timeframe: 28 days

Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=3 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 n=4 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 n=6 Participants All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 n=11 Participants All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28	2 Participants	3 Participants	2 Participants	4 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 6 days

Population: The PK analysis population is comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.

Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=9 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=6 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: Cmax	26.5 μg/mL Geometric Coefficient of Variation 16.0	52.2 μg/mL Geometric Coefficient of Variation 13.0	79.5 μg/mL Geometric Coefficient of Variation 30.0	—	—	—

SECONDARY outcome

Timeframe: 6 days

Population: The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.

Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=9 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=6 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: Tmax	0.25 hr Interval 0.22 to 1.12	0.31 hr Interval 0.27 to 7.35	0.31 hr Interval 0.23 to 0.37	—	—	—

SECONDARY outcome

Timeframe: 6 days

Evaluate the Area under the time-concentration curve \[AUC\] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=9 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B n=3 Participants All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=6 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: AUC	433 hr x μg/mL Geometric Coefficient of Variation 127	1509 hr x μg/mL Geometric Coefficient of Variation 80.1	2067 hr x μg/mL Geometric Coefficient of Variation 38.4	—	—	—

SECONDARY outcome

Timeframe: 6 days

Population: The PK analysis population comprised 19 patients for whom concentration data were available. Due to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.

Evaluate Total body clearance \[CL\] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=2 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=2 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: CL	0.053 L/hr Geometric Coefficient of Variation 2.57	—	0.053 L/hr Geometric Coefficient of Variation 70.5	—	—	—

SECONDARY outcome

Timeframe: 6 days

Evaluate the Volume of distribution \[Vz\] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=2 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=2 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: Vz	3.78 L Geometric Coefficient of Variation 33.9	—	5.32 L Geometric Coefficient of Variation 82.9	—	—	—

SECONDARY outcome

Timeframe: 6 days

Evaluate the Terminal elimination half-life \[t1/2\] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A n=2 Participants All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.	Part 1, Cohort B All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 1, Cohort E n=2 Participants All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.	Part 2, Group 2 All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.	Part 2, Group 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.	Part 3 All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
Evaluate Pharmacokinetic Parameters: t1/2	49.0 hr Geometric Coefficient of Variation 36.7	—	69.4 hr Geometric Coefficient of Variation 8.80	—	—	—

Adverse Events

Part 1, Cohort A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1, Cohort B

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1, Cohort E

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2, Group 2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2, Group 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 3

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1, Cohort A n=3 participants at risk ONM-100 at dose of 1 mg/kg.	Part 1, Cohort B n=3 participants at risk ONM-100 at dose of 3 mg/kg.	Part 1, Cohort E n=3 participants at risk ONM-100 at dose of 2 mg/kg.	Part 2, Group 2 n=4 participants at risk ONM-100 at dose of 3 mg/kg.	Part 2, Group 3 n=6 participants at risk ONM-100 at dose of 1 mg/kg.	Part 3 n=11 participants at risk ONM-100 at dose of 1 mg/kg.
Infections and infestations Cellulitis	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Infections and infestations Abscess neck	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Respiratory, thoracic and mediastinal disorders Tonsillar hemorrhage	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Vascular disorders Thrombophlebitis	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	25.0% 1/4 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Vascular disorders Superficial vein thrombosis	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	18.2% 2/11 • Number of events 2 • The total collection period for each subject was approximately one month.

Other adverse events

Other adverse events
Measure	Part 1, Cohort A n=3 participants at risk ONM-100 at dose of 1 mg/kg.	Part 1, Cohort B n=3 participants at risk ONM-100 at dose of 3 mg/kg.	Part 1, Cohort E n=3 participants at risk ONM-100 at dose of 2 mg/kg.	Part 2, Group 2 n=4 participants at risk ONM-100 at dose of 3 mg/kg.	Part 2, Group 3 n=6 participants at risk ONM-100 at dose of 1 mg/kg.	Part 3 n=11 participants at risk ONM-100 at dose of 1 mg/kg.
Injury, poisoning and procedural complications Infusion-related reaction	33.3% 1/3 • Number of events 2 • The total collection period for each subject was approximately one month.	66.7% 2/3 • Number of events 4 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	75.0% 3/4 • Number of events 6 • The total collection period for each subject was approximately one month.	66.7% 4/6 • Number of events 8 • The total collection period for each subject was approximately one month.	63.6% 7/11 • Number of events 24 • The total collection period for each subject was approximately one month.
Injury, poisoning and procedural complications Buttock injury	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Injury, poisoning and procedural complications Neck injury	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Constipation	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Nausea	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	25.0% 1/4 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Gastrointestinal disorders Oral pain	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Neck pain	66.7% 2/3 • Number of events 2 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	25.0% 1/4 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Fatigue	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Injection site reaction	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	25.0% 1/4 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Malaise	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Pain	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Pyrexia	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Nervous system disorders	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
General disorders Dizziness	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	9.1% 1/11 • Number of events 1 • The total collection period for each subject was approximately one month.
General disorders Headache	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
General disorders Sensory disturbance	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • The total collection period for each subject was approximately one month.	0.00% 0/3 • The total collection period for each subject was approximately one month.	33.3% 1/3 • Number of events 1 • The total collection period for each subject was approximately one month.	0.00% 0/4 • The total collection period for each subject was approximately one month.	0.00% 0/6 • The total collection period for each subject was approximately one month.	0.00% 0/11 • The total collection period for each subject was approximately one month.

Additional Information

Vice President, Clinical Operations

OncoNano Medicine, Inc.

Phone: 682-285-1411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place