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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735680
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Head and Neck Squamous Cell Carcinoma Colorectal Cancer Prostate Cancer Ovarian Cancer Urothelial Carcinoma Non-small Cell Lung Cancer Drug: ONM-100 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety, and 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
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020


Arm Intervention/treatment
Experimental: Patients receiving ONM-100
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
Drug: ONM-100
A polymer micelle covalently conjugated to indocyanine green, an FDA-approved fluorophore




Primary Outcome Measures :
  1. Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)] [ Time Frame: 1 day ]
  2. Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Evaluate pharmacokinetic parameters: Cmax [ Time Frame: 6 days ]
    Maximum plasma concentration [Cmax]

  2. Evaluate pharmacokinetic parameters: Tmax [ Time Frame: 6 days ]
    Time to Cmax [Tmax]

  3. Evaluate pharmacokinetic parameters: AUC [ Time Frame: 6 days ]
    Area under the time-concentration curve [AUC]

  4. Evaluate pharmacokinetic parameters: CL [ Time Frame: 6 days ]
    Total body clearance [CL]

  5. Evaluate pharmacokinetic parameters: Vss [ Time Frame: 6 days ]
    Volume of distribution [Vss]

  6. Evaluate pharmacokinetic parameters: t1/2 [ Time Frame: 6 days ]
    Terminal elimination half-life [t1/2]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735680


Contacts
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Contact: Yalia Jayalakshmi, PhD 650-861-0608 jaya@onconanomed.com

Locations
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United States, Pennsylvania
The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ari Brooks, MD         
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Herbert Zeh, MD         
The University of Texas - M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Kelly Hunt, MD         
Sponsors and Collaborators
OncoNano Medicine, Inc.
Investigators
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Study Director: Yalia Jayalakshmi, PhD OncoNano Medicine, Inc.

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Responsible Party: OncoNano Medicine, Inc.
ClinicalTrials.gov Identifier: NCT03735680    
Other Study ID Numbers: ON-1002
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Head and Neck Neoplasms