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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 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-01-22

No results posted yet for this 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

Interventions

DRUG

2B3-101

IV every 21 days

DRUG

Trastuzumab

IV every 21 days

DRUG

2B3-101 60 mg/m2 every 4 weeks

IV every 28 days

DRUG

2B3-101 50 mg/m2 every 3 weeks

IV every 21 days

Sponsors & Collaborators

  • BBB-Therapeutics B.V.

    lead INDUSTRY

Principal Investigators

  • J. Veeneman, PhD · BBB Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Belgium
  • France
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386580 on ClinicalTrials.gov