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NCT01479023 · ClinicalTrials.gov registry record · Phase 1
Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01479023 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 12 participants.
The verdict
NCT01479023, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
2.1 Primary Objectives 1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only) 2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5)) 3. To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts) 2.2 Secondary Objectives 1. To determine the relationship between U3-1287 serum concentration and HER3 receptor occupancy (as measured by PET/CT) in subjects with advanced solid tumors 2. To measure the tumor response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2 only) 3. To characterize the PK exposure of U3 1287 when administered intravenously to patients with advanced solid malignancies. 4. To measure the rate of anti-U3-1287 human antibody development in subjects with advanced solid tumors treated with U3 1287 monotherapy 2.3 Exploratory Objectives 1. To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance imaging (MRI) (Part 2 only) 2. To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g., proteins and transcripts) that predict response to U3-1287 3. To obtain tumor samples for DNA extraction for analysis of potential predictors of response to U3-1287 and any related genes as suggested by emerging data
Interventions
- DRUG 64Cu-DOTA-U3-1287
- DRUG U3-1287 (unlabeled)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01479023
The ClinicalTrials.gov registry entry for NCT01479023 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 64Cu-DOTA-U3-1287 is the first listed.
NCT01479023 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01479023 about?
NCT01479023 is a clinical study titled "Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors". 2.1 Primary Objectives 1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only) 2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing u...
What is the current status of trial NCT01479023?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-04. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01479023?
The interventions under investigation include: 64Cu-DOTA-U3-1287 (DRUG), U3-1287 (unlabeled) (DRUG).
Who is sponsoring clinical trial NCT01479023?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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