Clinical trial · Interventional
Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma
Multi-national, Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma, Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week
NCT00431561CI-TRIAL-00012804completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult patients with confirmed recurrent high-grade glioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AP 12009 10 µM | Drug | — | UNRESOLVED |
| AP 12009 80 µM | Drug | — | UNRESOLVED |
| Drug delivery system for administration of AP 12009 | Device | — | UNRESOLVED |
| Placement of Drug Delivery System | Procedure | — | UNRESOLVED |
| temozolomide or PCV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AP 12009 10 µM
- interventionNames
- Drug: AP 12009 10 µM
- Device: Drug delivery system for administration of AP 12009
- Procedure: Placement of Drug Delivery System
- type
- EXPERIMENTAL
- label
- AP 12009 80 µM
- interventionNames
- Drug: AP 12009 80 µM
- Device: Drug delivery system for administration of AP 12009
- Procedure: Placement of Drug Delivery System
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- interventionNames
- Drug: temozolomide or PCV
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV) * Supratentorial localization * No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis * Eligible for either TMZ or PCV treatment * Recovery from acute toxicity caused by any previous therapy * Adequate organ functions * KPS at least 70% Exclusion Criteria: * Tumor surgery within 2 weeks prior to study entry * Radiation therapy within 8 weeks prior to study entry * Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks) * No more than 3 mg/day dexamethasone (or equivalent) at baseline * Prior TGF-beta targeted therapy or tumor vaccination * Baseline MRI shows mass effect * Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection * Significant psychiatric disorders/legal incapacity or a limited legal capacity
References
Publications (1)
- DERIVEDUckun FM, Qazi S, Hwang L, Trieu VN. Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFbeta2-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up. Cancers (Basel). 2019 Nov 28;11(12):1892. doi: 10.3390/cancers11121892. PMID 31795071