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

Thallion Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Glioblastoma Multiforme

Treatments

Drug: TLN-4601

Study type

Interventional

Funder types

Industry

Identifiers

NCT00730262

TLN-4601-201

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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