Completed

A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

What is being tested

Sativex

+ Placebo

Drug

Who is being recruted

Neoplasms

Over 18 Years

+34 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2

Interventional

Study Start: September 2014

See protocol details

Summary

Principal SponsorJazz Pharmaceuticals

Last updated: December 20, 2022

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2014

Actual date on which the first participant was enrolled.

Patients will receive Sativex and dose-intense Temozolomide in an open-label phase. The incidence of adverse events will be monitored (Part A). An investigator led Safety Review Team will assess the safety profile of the open-label patients and decide whether the study can progress to the randomisation phase (Part B). Patients who enrol in the randomisation phase patients will receive either Sativex or placebo. The safety of Sativex compared to placebo will be assessed by pharmacokinetic analysis of Temozolomide and its metabolites, clinical laboratory tests, adverse events and vital signs.

NCT01812616

Principal SponsorJazz Pharmaceuticals

Last updated: December 20, 2022

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

9 inclusion criteria required to participate

Evidence of patients first tumour progression (as determined by Revised Assessment in Neuro-Oncology) following radiation and first line chemotherapy with Temozolomide

Histopathologically confirmed diagnosis of grade four Glioblastoma Multiforme as per World Health Organisation classification

If taking steroids, then the dose must be stable or decreasing

Karnofsky performance scale of 60% or greater

Show More Criteria

25 exclusion criteria prevent from participating

Any history of a different malignancy unless the patient has remained disease-free for at least three years and are at low risk for recurrence of that malignancy (cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin are exempt from this criterion if treatment has occurred)

Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition

Any known allergy to or other intolerability to Temozolomide

Any known or suspected history of a substance abuse/dependence disorder, current heavy alcohol consumption ( > 60g of pure alcohol per day for men, > 40 g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Patients will received Sativex and Dose-Intense Temozolomide in a double-blind manner

Group II

Placebo

Patients will received placebo and Dose-Intense Temozolomide and in double-blind manner

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Klinik für Onkologie, Hämatologie und Stammzelltransplantation, Universitätsklinikum Aachen RWTH

Aachen, GermanyOpen Klinik für Onkologie, Hämatologie und Stammzelltransplantation, Universitätsklinikum Aachen RWTH in Google Maps

Neurologie des Klinikums Altenburger Land

Altenburg, Germany

Zentrum für Neuroonkologie der Universität Duesseldorf

Düsseldorf, Germany

Strahlenklinik der Universität Erlangen

Erlangen, Germany

Completed11 Study Centers