A study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.
Recruiting
- Conditions
- solid tumors, brain metastasessolide tumoren, hersenmetastasenRecurrent Malignant Glioma
- Registration Number
- NL-OMON26600
- Lead Sponsor
- to-BBB Technologies B.V.to-BBB technologies BVNiels Bohrweg 11, 2333 CA LeidenBio Partner Center IIThe NetherlandsPhone: +31 (0) 71 3322256Fax: +31 (0) 84 8313409Email: gladdines@tobbb.com
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Age at least 18 years;
2. Measurable or evaluable brain disease;
Exclusion Criteria
Prior Treatment:
1. Less than 4 weeks since the last treatment of chemotherapy, biological therapy, immunotherapy and systemic radiotherapy (except palliative radiation delivered to <20% of bone marrow), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma, in order to determine the Maximum Tolerated Dose (MTD).
- Secondary Outcome Measures
Name Time Method 1. To examine the pharmacokinetics (PK) in plasma of 2B3-101 in terms of Cmax, Vss, T1/2, AUC, CL;<br /><br>2. To obtain preliminary information on the clinical anti-tumor activity of 2B3-101 in terms of objective response rate and duration of response.