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Brief Title: ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety & Timing of Postdose Imaging of ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Solid Tumors Undergoing Routine Surgery

INTRODUCTION

  • Org Study ID: ON-1002
  • Secondary ID: N/A
  • NTC ID: NCT03735680
  • Sponsor: OncoNano Medicine, Inc.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    August 9, 2019
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)]

Primary Outcome 1 - Timeframe: 1 day

Primary Outcome 2 - Measure: Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28

Primary Outcome 2 - Timeframe: 28 days

CONDITION

  • Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Colorectal Cancer
  • Prostate Cancer
  • Ovarian Cancer
  • Urothelial Carcinoma
  • Non-small Cell Lung Cancer

ELIGIBILITY

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 <12 weeks - Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Trials@OncoNanoMed.com

Role: Study Director

Affiliation: OncoNano Medicine, Inc.

Overall Contact

Name: Trials@OncoNanoMed.com

Phone: +1(682)285-1411

Email: Trials@OncoNanoMed.com

LOCATION

Facility Status Contact
Facility: The University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Jason Newman, MD

Facility: The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Herbert Zeh, MD

Facility: The University of Texas - M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Ann Gillenwater, MD