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APG101 in Glioblastoma

Study Purpose

This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101. APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end). In this trial, 30-35 sites in Germany, Austria and Russia take part.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence.
  • - Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI.
MRI images must not be older than 2 weeks before first dosing/start of RT.
  • - Not more than two prior therapy regimens including one or two resections, one or two chemotherapies of which one must have been TMZ-containing and one radiotherapy (RT) for the brain tumour.
  • - Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation.
  • - Candidate for reirradiation with recurrent tumour visible on MRI-T1 (Gd) and with the largest diameter measuring 1 cm to 4 cm.
  • - Informed consent.
  • - Age at least 18 years, smoking or non-smoking, of any ethnic origin.
  • - Karnofsky performance index (KPI) ≥ 60% - Neutrophile counts > 1500/μl / Platelet counts > 80.000/μl / Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range.
  • - Adequate contraception.
  • - Stable or decreasing treatment with steroids within 5 days before treatment start.

Exclusion Criteria:

  • - More than one RT of brain, prior first radiotherapy with more than 60 Gy.
  • - Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, α/β=2.
  • - Prior treatment with bevacizumab, iodine seeds and/or brachytherapy.
  • - Unable to undergo MRI.
  • - Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation.
  • - HIV or hepatitis infection.
  • - Pregnancy or breast feeding.
  • - Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion.
- Known active coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III - IV)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01071837
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Apogenix GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wolfgang Wick, MD
Principal Investigator Affiliation University Hospital Heidelberg, Dept. of Neurooncology, Germany
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Austria, Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

In this phase II trial, patients with a recurrence / progression of glioblastoma (first or second progression) either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly intravenous infusion. Radiotherapy (RT) is considered standard of care and not a study procedure. As prior therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of preirradiation), a prior surgery (at least for histology) and at least one Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose must be stable or decreasing upon inclusion. The number of patients to be included in this study is up to 83 (depending on the statistical 2-step SIMON design). Primary objective: 6 months rate of progression free survival (PFS6). Subjects can participate in this study as long as a clinical benefit is considered by the treating physician. MRI tumour imaging will be carried out every 6 weeks.

Arms & Interventions

Arms

Active Comparator: Re-Irradiation

33% of the patients will be randomized to reirradiation (RT) alone. They will receive 36 Gy (2 Gy per fraction)

Experimental: Re-Irradiation + APG101

66% of the patients will be randomized to reirradiation (RT) + 400 mg APG101 weekly. They will receive 36 Gy (2 Gy per fraction) and 400 mg APG101 weekly as an intravenous infusion

Interventions

Drug: - APG101

400mg weekly as intravenous infusion

Procedure: - Blood drawing

Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Graz, Austria

Status

Address

Medizinische Universität Graz, Universitätsklinik für Neurologie Landeskrankenhaus Graz

Graz, , 8036

Innsbruck, Austria

Status

Address

Universitätsklinik für Neurologie, Landeskrankenhaus Innsbruck

Innsbruck, , 6020

Linz, Austria

Status

Address

Landesnervenklinik Wagner-Jauregg, Innere Medizin mit Neuroonkologie

Linz, , 4020

Wien, Austria

Status

Address

Allgemeines Krankenhaus der Stadt Wien, Klinische Onkologie

Wien, , 1090

Berlin, Germany

Status

Address

Charite Universitätsmedizin Berlin, Klinik für Neurochirugie

Berlin, , 13353

Bochum, Germany

Status

Address

Neurologische Universitätsklinik am Knappschaftskrankenhaus

Bochum, , 44892

Bonn, Germany

Status

Address

Neurologische Universitätsklinik Bonn, Schwerpunkt klinische Neuroonkologie

Bonn, , 53105

Dresden, Germany

Status

Address

Universitätsklinik Dresden, Klinik und Poliklinik für Neurochirurgie

Dresden, , 01307

Frankfurt/Oder, Germany

Status

Address

Klinikum Frankfurt/Oder, Klinik für Strahlentherapie/Radioonkologie

Frankfurt/Oder, , 15236

Hamburg, Germany

Status

Address

Universitätsklinik Hamburg, Klinik für Neurochirugie

Hamburg, , 20246

Heidelberg, Germany

Status

Address

Universitätsklinik Heidelberg, Abteilung Neuroonkologie

Heidelberg, , 69120

Leipzig, Germany

Status

Address

Universität Leipzig, Klinik für Strahlentherapie

Leipzig, , 04103

Mannheim, Germany

Status

Address

Universitätsmedizin Mannheim, Klinik für Neurochirurgie

Mannheim, , 68167

Marburg, Germany

Status

Address

Philipps-Universität Marburg, Klinik für Neurologie

Marburg, , 35039

München, Germany

Status

Address

LMU München, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Campus Großhadern & Campus Innenstadt

München, , 81377

München, Germany

Status

Address

Klinik und Poliklinik für Strahlentherapie/Radiologische Onkologie, Klinikum rechts der Isar, TU München

München, , 81675

München, Germany

Status

Address

Städt. Kliniken München GmbH, Klinikum Bogenhausen, Abt. Neurochirurgie

München, , 81925

Regensburg, Germany

Status

Address

Klinik und Poliklinik der Universität Regensburg, Im Bezirksklinikum

Regensburg, , 93053

Stuttgart, Germany

Status

Address

Klinikum Stuttgart, Neurozentrum Neurochirurgie

Stuttgart, , 70174

Tuebingen, Germany

Status

Address

Universitätsklinikum Tuebingen, Strahlenonkologie

Tuebingen, , 72076

Ulm, Germany

Status

Address

Uniklinik Ulm, Klinik für Strahlentherapie und Radioonkologie

Ulm, , 89081