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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730262

Enrollment

Registered

2008-08-08

Start date

2008-08-31

Completion date

2010-06-30

Last updated

2009-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme (GBM), Phase II, Brain Cancer

Brief summary

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.

Interventions

DRUGTLN-4601

14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026