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NCT01386580 · ClinicalTrials.gov registry record · Phase 1
An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.
A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by BBB-Therapeutics B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 10
- Study locations
NCT01386580: Completed Phase 1 study of Breast Cancer and Lung Cancer, sponsored by BBB-Therapeutics B.V..
NCT01386580 is a Phase 1 study of Breast Cancer and Lung Cancer that has completed, run by BBB-Therapeutics B.V.. The registered enrollment target is 84 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386580, a Phase 1 study of Breast Cancer and Lung Cancer, has completed, sponsored by BBB-Therapeutics B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and brain metastases or recurrent malignant glioma as well as in patients with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast cancer patients with brain metastases.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG 2B3-101
- DRUG 2B3-101 60 mg/m2 every 4 weeks
- DRUG 2B3-101 50 mg/m2 every 3 weeks
Study Locations (10)
Other
- Universitair Ziekenhuis Antwerpen - Antwerp
- Jules Bordet Institute - Brussels
- Antoni van Leeuwenhoek Ziekenhuis - Amsterdam
- Vrije Universiteit medisch centrum (Vumc) - Amsterdam
- Leids Universitair Medisch Centrum (LUMC) - Leiden
- Maastricht Universitair Medisch Centrum - Maastricht
- Erasmus MC - Rotterdam
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Paris Cedex 05
- Institut Curie - Paris
Val de Marne
- Institut Gustave Roussy - Villejuif
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01386580 record still lists
NCT01386580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT01386580 lists 10 locations in 4 states (Other, North Carolina, Paris Cedex 05).
Frequently Asked Questions
What is clinical trial NCT01386580 about?
NCT01386580 is a clinical study titled "An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.". The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and ...
What is the current status of trial NCT01386580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2011-07. Estimated completion is 2014-12.
What conditions does trial NCT01386580 study?
This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Melanoma, Brain Metastases, Malignant Glioma.
What interventions are being tested in trial NCT01386580?
The interventions under investigation include: Trastuzumab (DRUG), 2B3-101 (DRUG), 2B3-101 60 mg/m2 every 4 weeks (DRUG), 2B3-101 50 mg/m2 every 3 weeks (DRUG).
Who is sponsoring clinical trial NCT01386580?
This trial is sponsored by BBB-Therapeutics B.V., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01386580 being conducted?
This trial has 10 study locations across North Carolina, Paris Cedex 05, Val de Marne. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01386580's enrollment target sits among peer trials
84 633rd of 1224 higher than 589 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
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