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Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma

Phase Ib/II Multicentric Study Combining Glasdegib (PF-04449913) With Temozolomide in Patients With Newly Diagnosed Glioblastoma, Safety and Preliminary Efficacy for the Combination

NCT03466450•Grupo Español de Investigación en Neurooncología

View on ClinicalTrials.gov

Summary

Glioblastomas (GBMs) are the most common malignant primary brain tumors. Despite multimodality aggressive therapies (surgery followed by chemoradiotherapy based on TMZ and adjuvant TMZ), median overall survival is only 12 to 15 months. This dramatic behavior is mainly due to the high invasiveness and proliferation rate of GBM. In addition, GBM exhibits a high resistance to standard chemotherapy and radiotherapy. Current strategies for the treatment of GBM are only palliative, and include surgical resection (which is frequently incomplete due to the proximity of the tumour to vital brain structures) and focal radiotherapy. A large number of chemotherapeutic agents (e.g. alkylating agents such as TMZ and nitrosoureas such as carmustine) have also been tested, but they display limited efficacy. The current gold standard first line treatment for glioma for patients less than 70 years old includes radiation and concurrent TMZ followed by adjuvant TMZ (i.e., the "Stupp regimen"). However, results are disappointing and there is an unmet medical need of new drugs in this setting. Glasdegib (SHH pathway inhibitor) is a rational therapeutic agent for patients with newly diagnosed Glioblastoma since inhibits SHH pathway interfering with cancer stem cells and endothelial migration.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to understand and the willingness to sign a written informed consent document.
•Male or Female ≥18 years old.
•Newly diagnosed GBM confirmed by biopsy or resection no more than 4 to 6 weeks before registration.
•Patients candidates for Stupp treatment
•Patients must have at least 15 unstained slides or 1 tissue block (frozen or paraffin embedded) available from a prior biopsy or surgery (archival tumor material).
•Patients must have sufficient time for recovery from prior surgery (at least 4 weeks).
•ECOG ≤ 1.
•Adequate hematologic function: Hematocrit ≥ 29%, Leukocytes \> 3,000/mcL, ANC ≥ 1,500 cells/ul, platelets ≥ 100,000 cells/ul.
•Adequate liver function: Bilirubin ≤ 2 x ULN; AST (SGOT) ≤ 2.5 X ULN
•Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min for subjects with creatinine levels above institutional normal.
+9 more criteria

Exclusion Criteria

•Presence of extracranial metastatic disease.
•Participants may not be receiving any other investigational agents.
•Patients must not have received prior Gliadel wafers.
•Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures.
•Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
•Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form.
•Congenital or known history of long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia, right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Association class III or IV).
•Current (or within 6 months) significant cardiovascular disease, including, but not limited to myocardial infarction, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism, bradycardia defined as \<50 bpms.
•Active cardiac dysrhythmias of NCI CTCAE Grade ≥2 (eg, atrial fibrillation) or QTcF interval (QTc using Fridericia's formula) \>470 msec.
•Active and clinically significant infections.
+1 more criteria

Locations (8)

Institut Catalá de Oncología Badalona/Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Institut Catalá de Oncología Girona/Hospital Universitari Dr. Josep Trueta

Girona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Key Dates

Start Date

March 15, 2018

Primary Completion Date

November 29, 2023

Completion Date

November 29, 2023

Last Updated

March 28, 2024

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

PF-04449913

DRUG

Temozolomide Oral Capsule

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

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