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A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer

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Trial Information

A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies


Inclusion Criteria:



- Diagnosis of advanced solid malignancy.

- Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian,
pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer

- Disease must be at least 1cm in diameter

- Brain metastasis must be stable for at least one month.

- ECOG performance status 0-2

Exclusion Criteria:

- Skin lesions only

- Chemotherapy or radiotherapy within 1 week

- Residual toxicities of grade 2 or greater from prior therapy

- Adequate organ function as per specified laboratory parameter

- Platelet count > or = to 160,000/uL

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Optimal Imaging Parameters

Outcome Description:

To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Glenn Liu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO12901

NCT ID:

NCT01662284

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
  • Esophageal Diseases
  • Head and Neck Neoplasms
  • Sarcoma

Name

Location

University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669