GlioblastomaPhase 1/2NCT04772846
Chloroquine for Glioblastoma.
A Phase 1/2 study testing Oral tablet in people with Glioblastoma, run by Egyptian Medical Syndicate at 1 site in Egypt.
Trial summary
Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks
Who cannot join
- Abnormal severe un-controlled medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.
Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.
- Conditions
- Glioblastoma
- Being tested
- Oral tablet, Placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tabletDrug
Oral 250mg chloroquine tablets
PlaceboDrug
Oral placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine group | Experimental | Not described Receives: Drug: Oral tablet |
| Placebo drug group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival duration after surgery
Measured: Three years
Secondary outcomes (1)
End-point evaluation, survival at three years
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Mar 2018
- Primary completion1 Dec 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Medical Syndicate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed A. Azab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772846
- Sponsor's protocol ID
- CQGBM
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.
- ClinicalTrials.gov ID
- NCT04772846
- Acronym / sponsor ID
- CQGBM
- Conditions
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Egyptian Medical SyndicateUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine group | Experimental | Drug: Oral tablet |
| Placebo drug group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks
Key exclusion criteria (1 listed)
- Abnormal severe un-controlled medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral tabletOral 250mg chloroquine tablets | Drug | Chloroquine group |
| PlaceboOral placebo tablets | Drug | Placebo drug group |
Primary outcome
Survival duration after surgery
Time frame: Three years
1 secondary outcome
End-point evaluation, survival at three years
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral tablet in people with Glioblastoma, run by Egyptian Medical Syndicate at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival duration after surgery (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.