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COMPLETED 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.

NCT01386580 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 84 participants
Start Date 2011-07
Est. Completion 2014-12
Phase Phase 1

Sponsor

BBB-Therapeutics B.V.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01386580

The ClinicalTrials.gov registry entry for NCT01386580 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BBB-Therapeutics B.V., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01386580 reports 10 study locations spanning 4 distinct geographic areas — top geographies include Other, North Carolina, Paris Cedex 05. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial