Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme (NCT02331498) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
France51 participantsStarted 2015-06
Plain-language summary
A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
* Age ≥ 18 years and \< 70 years
* Histologically confirmed diagnosis of GBM
* Surgically treated other than exclusive biopsy (complete or partial resection) of the GBM, for which adjuvant radiotherapy and chemotherapy is indicated
* Eligibility criteria that will need to be checked before patient registration and - No TMZ interruption resulting in hematological toxicity should has occurred
* AND the delivery of radiation dose as defined in the Stupp protocol should be at least equal to 80%
* Eastern Cooperative Oncology Group (ECOG) performance status of Glioblastoma ≤ 2
* Life expectancy\>3 months
* Measurable disease criteria : Based on the RANO criteria (Wen 2010) objective tumor response will be assessed by MRI and 18F-DOPA PET)
* Archived tumor tissue must be available for all subjects for biomarker analysis before and/or during treatment with investigational product.
* Stable doses of corticosteroid for more than 1 week.
* Adequate biological function
* Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in Pregnancy Section in overall Safety Section during the study and for 6 months following the last dose of investigational product.
Exclusion Criteria:
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What they're measuring
1
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