Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isarna Therapeutics GmbH
• Treatments: Lomustine; Temozolomide; Trabedersen

Criteria

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