Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.

Official Title
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A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: TLN-4601


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed Glioblastoma Multiforme (GBM) Prior treatment with radiation and one first line systemic therapy (including temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination therapies), followed by measurable and unequivocal evidence of tumor progression or recurrence Age ≥ 18 years ECOG ≤ 2 Normal organ and marrow function as defined below: leukocytes ≥3 x 109/L absolute neutrophil count ≥1.5 x 109/L platelets ≥100 x 109/L hemoglobin ≥90 g/L total bilirubin ≤2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal creatinine ≤1.0 X institutional upper limit of normal Exclusion Criteria: Patients with a life expectancy < 12 weeks Patients with a documented history of HIV, active hepatitis B or C infections Female patients who are pregnant or lactating Patients in whom a proper central line (Portacath-like device) cannot be established Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or polysorbate 80 Patients with uncontrolled hypotension Patients with concomitant therapy of therapeutic coumadin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Arm<br> | Drug: TLN-4601<br>* 14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period<br>* Other names: Formerly ECO-4601;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1). |  | 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM |  | Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma Multiforme (GBM), Phase II, Brain Cancer