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NCT00526045 · ClinicalTrials.gov registry record · Phase 1
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
NCT00526045 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 117 participants.
The verdict
NCT00526045, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
Study Summary
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed.
Interventions
- DRUG AUY922 2 mg/m2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00526045
The ClinicalTrials.gov registry entry for NCT00526045 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AUY922 2 mg/m2 is the first listed.
NCT00526045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00526045 about?
NCT00526045 is a clinical study titled "Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients". This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or me...
What is the current status of trial NCT00526045?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2007-07. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00526045?
The interventions under investigation include: AUY922 2 mg/m2 (DRUG).
Who is sponsoring clinical trial NCT00526045?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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