Phase 2
N=30
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
Breast Cancer · Head and Neck Squamous Cell Carcinoma · Colorectal Cancer · Prostate Cancer · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03735680 ↗Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Jul 2023
Primary outcome: Primary: Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)] — 1.098; 4.022; 2.280; 4.110 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ONM-100 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OncoNano Medicine, Inc.
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)] |
1.098; 4.022; 2.280; 4.110; 3.007; 2.608 | — |
| PRIMARY Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28 |
2; 3; 2; 4; 6; 9 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: Cmax |
26.5; 52.2; 79.5 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: Tmax |
0.25; 0.31; 0.31 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: AUC |
433; 1509; 2067 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: CL |
0.053; 0.053 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: Vz |
3.78; 5.32 | — |
| SECONDARY Evaluate Pharmacokinetic Parameters: t1/2 |
49.0; 69.4 | — |
Summary
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
Eligibility Criteria
Inclusion Criteria
- Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
- Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
- Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
- Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria
- Histologically diagnosed by an excisional biopsy procedure
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
- Life expectancy 5) or significant liver disease including active hepatitis or cirrhosis
Data sourced from ClinicalTrials.gov (NCT03735680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.