Clinical trial · Interventional
Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
NCT00730262CI-TRIAL-00002950terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TLN-4601 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-Arm
- interventionNames
- Drug: TLN-4601
Primary outcomes (1)
- measure
- 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).
- timeFrame
- 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Secondary outcomes (1)
- measure
- To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM
- timeFrame
- Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.