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NCT01480583 · ClinicalTrials.gov registry record · Phase 2
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
A Phase 2 study, sponsored by Angiochem.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT01480583 is a Phase 2 study that has completed, run by Angiochem. The registered enrollment target is 85 participants.
The verdict
NCT01480583, a Phase 2 study, has completed, sponsored by Angiochem.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice. In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).
Interventions
- DRUG Trastuzumab
- DRUG GRN1005
- DRUG 18F-FLT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01480583
The ClinicalTrials.gov registry entry for NCT01480583 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angiochem, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01480583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01480583 about?
NCT01480583 is a clinical study titled "GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases". The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care pract...
What is the current status of trial NCT01480583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2011-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01480583?
The interventions under investigation include: Trastuzumab (DRUG), GRN1005 (DRUG), 18F-FLT (DRUG).
Who is sponsoring clinical trial NCT01480583?
This trial is sponsored by Angiochem, which has 6 total clinical trials registered on ClinicalTrials.gov.
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