- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00761280
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma (SAPPHIRE)
Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to compare the safety and efficacy of the 10 µM concentration of AP 12009 and standard chemotherapy (temozolomide, BCNU, CCNU) in adult patients with recurrent or refractory anaplastic astrocytoma (AA, WHO grade III) or secondary glioblastoma (GBM, WHO grade IV). AP 12009 (trabedersen) is a phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human Transforming Growth Factor beta 2 (TGF-beta-2), which is applied intratumorally. The growth factor TGF-beta plays a key role in malignant progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis, and escape from immunosurveillance. In patients with high-grade glioma, the TGF-beta-2 overexpression is associated with disease stage, clinical prognosis, and the immunodeficient state of the patients. Main objective of the study is to determine survival (rate) and tumor response.
Important note: Due to early trial termination, resulting in limited data availability, all analyses remain descriptive by nature, only. No conclusive endpoint analysis can be performed.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ciudad Autónoma de Buenos Aires, Argentina, C1280AEB
- Hospital Británico
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Ciudad Autónoma de Buenos Aires, Argentina, C1428
- FLENI
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Córdoba, Argentina, X5000JHQ
- Sanatorio Allende
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Innsbruck, Austria, 6020
- Universitätsklinik Innsbruck, Abteilung für Neurologie
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Wien, Austria, 1090
- AKH Wien, Klinik für Neurochirurgie
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Barretos / SP, Brazil, 14784-400
- Hospital de Cancer de Barretos
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Goiania, Brazil, 74223-080
- Centro Goiano de Oncologia (CGO)
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Passo Fundo, Brazil, 99010-080
- Hospital Sao Vicente de Paulo
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Porto Alegre, Brazil, 90610-000
- Hospital São Lucas da PUCRS
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Porto Alegre, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Sao Paulo, Brazil, 04038-034
- Hospital do Servidor Publico Estadual
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Calgary, Canada, AB T2N 2T9
- Foothills Medical Centre
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Montreal, Canada, H3A 2B4
- Montreal Neurological Institute and Hospital
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7P2
- ECOGENE-21 Centre d'études cliniques
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Marseille, France, 13385
- La Timone University Hospital
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Frankfurt/M., Germany, 60528
- Klinik und Poliklinik für Neurochirurgie
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Freiburg, Germany, 79106
- Universitätsklinikum Freiburg
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Günzburg, Germany, 89312
- Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg
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Hamburg, Germany, 20246
- Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover Neurochirurgische Klinik
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Heidelberg, Germany, 69120
- Universitätsklinik Heidelberg Neurologische Klinik
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig, Neurochirurgische Klinik
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Magdeburg, Germany, 39120
- Otto-von-Guericke-Universität, Klinik für Neurochirurgie
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Münster, Germany, 48149
- Klinik und Poliklinik für Neurochirurgie
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Regensburg, Germany, 93053
- Klinik und Poliklinik für Neurologie
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Szeged, Hungary, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Bangalore, India, 560017
- Manipal Hospital & Manipal Institute for Neurological Disorders
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Bangalore, India, 560029
- NIMHANS
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Bangalore, India, 560060
- BGS Global Hospital
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Chandigarh, India, 160012
- Postgraduate Institute of Medical Education & Research (PGIMER)
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Chennai, India, 600006
- Apollo Speciality Hospitals
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Cochin, India, 560017
- Amrita Institute of Medical Sciences Research Center
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Hyderabaad, India, 500034
- Care Hospitals
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Kolkata, India, 700029
- AMRI Hospitals
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Lucknow, India, 226014
- SGPGI of Medical Sciences
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Mumbai, India, 410210
- Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
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New Delhi, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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Thiruvananthapuram, India, 695011
- SCTIMST, Dept. of Neurosurgery
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Seoul, Korea, Republic of, 120-752
- Severance Hospital, Yonsei University College of Medicine
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Seoul, Korea, Republic of, 137-701
- KangNam St. Mary's Hospital
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Guadalajara, Mexico, 44670
- Hospital San Javier
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Mexico City, Mexico, 06120
- Hospital General de México
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Mexico City, Mexico, 14050
- Médica Sur
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Bydgoszcz, Poland, 85-681
- Wojskowy Szpital Kliniczny, Klinika Neurochirurgii
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Gdańsk, Poland, 80-952
- Akademickie Centrum Kliniczne
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Lublin, Poland, 20-090
- Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej
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Sosnowiec, Poland, 41-200
- Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5
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Warszawa, Poland, 02-781
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
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Łódź, Poland, 91-153
- SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii
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Chelyabinsk, Russian Federation, 454021
- Chelyabinsk City Hospital #3; Department of Neurosurgery
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Moscow, Russian Federation, 115478
- State Institution Russian Oncology Research Center N.N. Blokhin
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Samara, Russian Federation, 443095
- Samara Region Clinical Hospital M.I. Kalinin
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St. Petersburg, Russian Federation, 191104
- Russian Scientific Research Neurosurgical Institute A.L. Polenov
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St. Petersburg, Russian Federation, 194044
- Military Medical Academy, Neurosurgery Dept
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Baracaldo, Spain, 48903
- Hospital de Cruces
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Barcelona, Spain, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Spain, 28041
- Hospital Doce de Octubre
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Santander, Spain, 39008
- Hospital Universitario Marqués De Valdecilla
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Taichung, Taiwan, 404
- China Medical University Hospital
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital
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Taipei City, Taiwan, 114
- Tri-Service General Hospital
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Edinburgh, United Kingdom, EH42XU
- Edinburgh Centre for Neuro-Oncology, Western General Hospital
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London, United Kingdom, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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New Jersey
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Edison, New Jersey, United States, 08820
- NJ Neuroscience Institute; JFK Medical Center
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New York
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Mineola, New York, United States, 11501
- Winthrop University Hospital
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient has provided written informed consent prior to any study-related procedure.
- The patient is at least 18 years of age and equal to or below 70 years.
- The patient has a present diagnosis of AA or secondary GBM.
- The patient has a measurable lesion (> 1 ccm in volume, central MRI review).
- The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).
- The tumor is localized supratentorially (central MRI review).
- All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
- The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
- The patient is eligible for chemotherapy.
- The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
- The patient is male or a non-pregnant, non-lactating female.
- Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.
- Females of childbearing potential and males must practice strict birth control.
- The patient must have recovered from acute toxicity caused by any previous therapy.
- The patient has a life expectancy of at least 3 months.
- The patient has a Karnofsky Performance Status of at least 70%.
The patient shows adequate organ functions as assessed by the following screening laboratory values:
- Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
- Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
- INR < 1.5 and aPTT < 1.5 x ULN
- Hemoglobin > 9 g/dL
- Platelet count > 100 x 10E9/L
- WBC > 3 x 10E9/L
- ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
Exclusion Criteria:
- Patient unable or not willing to comply with the protocol regulations.
- The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).
- Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a ≤48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.
- Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
- Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
- Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
- Prior anti-TGF-beta 2 targeted therapy.
- Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (≥ 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift ≥ 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
- Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.
- History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
- Presence of poorly controlled seizures.
- Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
- Known HIV, HBV or HCV infection.
- Acute viral, bacterial, or fungal infection.
- Acute medical problems that may be considered to become an unacceptable risk, or any conditions, which might be contraindications for starting study treatment.
Presence of high risk for pulmonary toxicities, defined as:
- Lung function: vital capacity ≤ 70%
- Status following sequential or concomitant thoracic irradiation
- Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
- History of allergies to reagents used in this study, history of celiac disease.
- Drug abuse or extensive use of alcohol.
- Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity.
- Concomitant treatment with yellow fever vaccine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: trabedersen 10 µM
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
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Other Names:
Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line).
Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice.
Stereotactical catheter placement controlled by CT.
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Active Comparator: Chemotherapy
temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles; carmustine: i.v.
administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles; lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
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Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Time Frame: 24 months
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Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization.
If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.
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24 months
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Survival at 24 Months in the Intent-to-treat Population - Number of Participants
Time Frame: 24 months
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Survival status was assessed at 24 months from randomization.
Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.
The category "Lost to / insufficient follow-up" includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Time Frame: 12, 18, and 21 months
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Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization.
Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.
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12, 18, and 21 months
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Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Time Frame: 12, 18, and 21 months
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Survival status was assessed at each time-point from randomization.
Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.
The category "Lost to follow-up" for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point.
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12, 18, and 21 months
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Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)
Time Frame: Up to 24 months
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Median overall survival was defined as the date of randomization to the date of death.
If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.
Analysis was by Kaplan-Meier estimation.
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Up to 24 months
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Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Time Frame: Up to 24 months
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Tumor response was classified based on the (neuro-)radiologist's evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:
Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response. |
Up to 24 months
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Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Time Frame: Up to 24 months
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Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.
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Up to 24 months
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Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Time Frame: Up to 24 months
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Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Participants with unknown or missing response were treated as non-responders.
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Up to 24 months
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Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)
Time Frame: Up to 24 months
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Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate. Censoring rules were:
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Up to 24 months
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Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Time Frame: 10, 12, 14, 16, 18, 21, and 24 months
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Tumor response was classified based on the (neuro-)radiologist's evaluation:
Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of "Progressed" versus "Not Progressed". Participants who had MRI assessment results missing or unknown were "UNK or missing", and were treated as "Progressed" for the purposes of the calculation. |
10, 12, 14, 16, 18, 21, and 24 months
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Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Time Frame: 10, 12, 14, 16, 18, 21 and 24 months
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Tumor response was classified based on the (neuro-)radiologist's evaluation:
Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of "Progressed" versus "Not Progressed". Participants who had MRI assessment results missing or unknown were "UNK or missing", and were treated as "Progressed" for the purposes of the calculation. |
10, 12, 14, 16, 18, 21 and 24 months
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Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)
Time Frame: Up to 24 months
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Time to progression was calculated from the date of randomization to the date of the first documented tumor progression.
Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.
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Up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Rolando Del Maestro, MD, PhD, Montreal Neurological Institute and Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Astrocytoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
- Carmustine
- Lomustine
- Trabedersen
Other Study ID Numbers
- AP 12009-G005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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