Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme (PAZOGLIO)
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|ClinicalTrials.gov Identifier: NCT02331498|
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Pazopanib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||March 2021|
Open label study with one group
Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.
- Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol, according the rate (33 %) of tolerate toxicities [ Time Frame: phase I ]To evaluate the Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol, regarding the toxicities that should not be more than 33 %
- overall tolerance of pazopanib : number of biological toxicities, blood pressure and hemorragic events [ Time Frame: 2 years ]To define the overall tolerance of pazopanib associated with TMZ during the maintenance phase of the "Stupp protocol" regarding biological toxicities, blood pressure and hemorragic events
- antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol [ Time Frame: 2 years ]To assess the antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol according to the Revised Assessment in Neuro-Oncology (RANO) criteria (response rate) and the median duration of response.
- determine the median Progression-Free-Survival [ Time Frame: 12 months ]To determine the median Progression-Free-Survival (mPFS), the PFS rate at 12 (PFS-12) months.
- determine the median Overall Survival (mOS) [ Time Frame: 12 months ]To determine the median Overall Survival (mOS), the OS rate at 6 (OS-6) and 12 (OS-12) months.
- pharmacokinetics profile: area under curve regarding plasma concentration /time between 0 and 8 h (AUC0-8 hours) from 0 to 24 h (AUC 0-24 hours), maximum plasma concentration (Cmax), time to the concentration maximum (Tmax) and plasma half-life (t1/2) [ Time Frame: 2 years ]To determine the pharmacokinetics (PK) profile of pazopanib when given in combination with TMZ.
- determine the pharmacokinetics (PK) profile of TMZ [ Time Frame: 2 years ]To determine the pharmacokinetics (PK) profile of TMZ when given in combination with pazopanib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331498
|Contact: Esma SAADA BOUZID, Mdemail@example.com|
|Contact: Christine LOVERAfirstname.lastname@example.org|
|Centre Antoine Lacassagne||Recruiting|
|Nice, Cedex 2, France, 06189|
|Contact: Esma SAADA BOUZID, Md +33492031618 email@example.com|
|Contact: Christine LOVERA +33492031618 firstname.lastname@example.org|
|Principal Investigator: Esma SAADA BOUZID, Dr|
|Sub-Investigator: Jérôme BARRIERE, Pr.|
|Sub-Investigator: Pierre Yves BONDIAU, Dr.|
|Study Director:||Christine LOVERA||Centre Antoine Lacassagne|