Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

NCT02331498 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 2012/49
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (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

  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 %

  phase I

Secondary Outcomes (6)

• overall tolerance of pazopanib : number of biological toxicities, blood pressure and hemorragic events

  2 years

• antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol

  2 years

• determine the median Progression-Free-Survival

  12 months

• determine the median Overall Survival (mOS)

  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)

  2 years

Study Arms (1)

A Pazopanib

OTHER

Open label study with one group

Drug: Pazopanib

Interventions

Pazopanib DRUG

Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.

A Pazopanib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior malignancy.
• Surgical treatment consisting in exclusive biopsy or absence of initial surgery
• Pre-treated GBM
• Allergy to any of the tested drugs
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including,
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
• Corrected QT interval (QTc) \> 480 msecs
• History of any one or more of ardiovascular conditions within the past 6 months
• Poorly controlled hypertension
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
• Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
• Evidence of active bleeding or bleeding diathesis.
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
• Recent hemoptysis
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Centre Antoine Lacassagne

Nice, Cedex 2, 06189, France

Location

Related Links

• website

MeSH Terms

Conditions

Glioblastoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Christine LOVERA

  Centre Antoine Lacassagne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: January 6, 2015
• Study Start: June 1, 2015
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)