NCT04772846

Brief Summary

Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

February 24, 2021

Last Update Submit

February 25, 2021

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Survival duration after surgery

    Three years

Secondary Outcomes (1)

  • End-point evaluation, survival at three years

    Three years

Study Arms (2)

Chloroquine group

EXPERIMENTAL
Drug: Oral tablet

Placebo drug group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Oral tabletDRUG

Oral 250mg chloroquine tablets

Chloroquine group
PlaceboDRUG

Oral placebo tablets

Placebo drug group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks

You may not qualify if:

  • Abnormal severe un-controlled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private clinics

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Tablets

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurosurgery

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 26, 2021

Study Start

March 1, 2018

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

EG(1)