Newly Diagnosed GlioblastomaPhase 1/2NCT04065087
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma
A Phase 1/2 study testing GX-I7 in people with Newly Diagnosed Glioblastoma, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Newly Diagnosed Glioblastoma
- What is being tested?
- GX-I7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2019to 27 Aug 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF)
- Age ≥ 19 years
- Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
- Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
- Karnofsky score ≥ 60
- Life expectancy > 12 weeks
Who cannot join
- Gliomatosis cerebri
- Isocitrate dehydrogenase 1 \& 2 mutation
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma
This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)
Read the detailed description
In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose.
Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.
- Conditions
- Newly Diagnosed Glioblastoma
- Being tested
- GX-I7, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7Biological
Investigational drug
PlaceboOther
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| GX-I7 | Experimental | GX-I7 administered until Progression of Disease Receives: Biological: GX-I7 |
| Placebo | Placebo comparator | Placebo administered until Progression of Disease Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte count
Change in absolute lymphocyte count
Measured: 12 weeks
Secondary outcomes (2)
Overall survival
Median overall survival
Measured: 36 months
Progression free survival
Median progression free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start22 Aug 2019 (estimated)
- Primary completion27 May 2022 (estimated)
- Study completion27 Aug 2022 (estimated)
Why it stopped: Canceled by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed 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
- Model description
- Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065087
- Sponsor's protocol ID
- GX-I7-CA-007
- Status last verified
- Mar 2022
- First submitted
- 25 Jul 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma
- ClinicalTrials.gov ID
- NCT04065087
- Acronym / sponsor ID
- GX-I7-CA-007
- Conditions
- Newly Diagnosed Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Canceled by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (estimated)
- Primary completion
- 27 May 2022 (estimated)
- Study completion
- 27 Aug 2022 (estimated)
- First posted
- 22 Aug 2019 (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.
This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)
Detailed description
In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose.
Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
| Arm | Type | Receives |
|---|---|---|
| GX-I7 | Experimental | Biological: GX-I7GX-I7 administered until Progression of Disease |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered until Progression of Disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form (ICF)
- Age ≥ 19 years
- Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
- Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
- Karnofsky score ≥ 60
Key exclusion criteria (3 listed)
- Gliomatosis cerebri
- Isocitrate dehydrogenase 1 \& 2 mutation
- Pregnant or breast feeding women
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 |
|---|---|---|
| GX-I7Investigational drug | Biological | GX-I7 |
| PlaceboPlacebo drug | Other | Placebo |
Primary outcome
lymphocyte count
Time frame: 12 weeks
Change in absolute lymphocyte count
2 secondary outcomes
Overall survival
Time frame: 36 months
Progression free survival
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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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 GX-I7 in people with Newly Diagnosed Glioblastoma, run by Genexine, Inc. at 1 site in South Korea.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Mar 2022. 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
lymphocyte count (time frame: 12 weeks). 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 17 Mar 2022.