GlioblastomaPhase 2/3NCT03008148
Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBM
A Phase 2/3 study testing CCRT, Temozolomide and Siroquine in people with Glioblastoma, run by Johnpro Biotech, Inc. at 2 sites in Taiwan.
Trial summary
This is a multi-center, phase II/III, open-label, randomized, parallel and standard chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to receive control treatment or study treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CCRT, Temozolomide and Siroquine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 Oct 2018to Apr 2025
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically proven newly diagnosed case of GBM (WHO grade IV) and treatment-naive (chemotherapy and radiotherapy) for GBM. Diagnosis must be made by stereotactic biopsy or surgical excision, either partial or complete within 3 months prior to Visit 1.
- Subject's RPA class is class III, IV or V.
- Subjects with stereotactic biopsy or brain surgery must be suited for or will be scheduled for CCRT followed by Temozolomide treatment, the standard treatment recommended by institutes and fulfilled the reimbursement guideline of National Health Insurance Administration.
- Subjects must have recovered from the effects of surgery, post-operative infection, and other complications prior to Visit 1. Study treatment must be performed > 3 weeks and ≤ 8 weeks after craniotomy. Ventricular fluid reservoir or Ventriculo-Peritoneal shunting tube is allowed to keep.
- A diagnostic contrast-enhanced MRI of the brain must be performed postoperatively within 28 days prior to Visit 2 (Day 1).
- ECOG performance status ≤ 3 at Visit 1.
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- Age from 20 to 80 years old at Visit 1.
- Life expectation ≥ 12 weeks at Visit 1.
- CBC/differential obtained at Visit 1, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 (1.5 x 109/L) or white blood cell (WBC) ≥ 3,000 cells/mm3 (3 x 109/L).
- Platelets count ≥ 100,000 cells/mm3 (100 x 109/L).
- Hemoglobin (Hgb or Hb) ≥ 10.0 g/dL (100 g/L) (Note: The use of transfusion or other intervention to achieve Hemoglobin ≥ 10.0 g/dL (100 g/L) is acceptable).
- Adequate renal function, as defined below:
- Creatinine ≤ 1.5 times upper laboratory limit at Visit 1.
- Adequate hepatic function, as defined below:
- Total Bilirubin ≤ 2.0 mg/dL (34.20 umol/L) at Visit 1.
- ALT ≤ 3 times upper laboratory limit at Visit 1.
- AST ≤ 3 times upper laboratory limit at Visit 1.
- Subjects is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).
Who cannot join
- Other invasive malignancy. However, subject with other invasive malignancy that have been disease-free more than or equal to 10 years and deemed no need for anti-cancer treatments can be recruited. Subjects with noninvasive malignancy, including carcinoma in situ of the breast, non-melanomatous skin cancer and cervix carcinoma in situ can be recruited if disease-free and treatment free more than or equal to 3 years.
- Metastases detected beyond the cranial vault.
- Subjects with the following history:
- Brain irradiation or Temozolomide usage.
- Macular degeneration or retinopathy.
- Renal transplantation.
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- Subjects are currently receiving any anti-rejection medicine or Hydroxychloroquine sulfate for rheumatoid arthritis.
- Subjects with severe and active co-morbidity, defined as follows:
- Clinical active kidney, liver, lung or cardiac disease.
- Acute bacterial or fungal infection requiring intravenous antibiotics at Visit 1 and acquired immune deficiency syndrome (AIDS).
- Any active infection or uncontrolled infection at Visit 1.
- Abnormal CXR finding with risks of infection and interstitial lung disease/pneumonitis.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant from study drug.
- Mean QTc > 500 msec (with Bazett's correction), history of familial long QT syndrome or other significant ECG abnormality noted at Visit 1.
- Known hypersensitivity reactions to Temozolomide, dacarbazine (DTIC), hydroxychloroquine, 4-aminoquinoline, rapamune, sirolimus, rapamycin, or their analogs.
- Women of child-bearing potential or men who are able to father a child unwilling to use a. medically acceptable method of contraception during the trial.
- Subjects participated in another investigational agent study in the past 30 days or are planning to do so during the study period.
- Subjects are considered ineligible for the study as judged by the investigator.
- Subjects with positive HBsAg or positive anti-HCV.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Yu-Ming Liu
- Not yet recruiting
Tri-Service General Hospital
Taipei, 11490
Hsin-I Ma
About this study
Official title: Randomized Phase II/III Trial of Radiotherapy Plus Concomitant and Adjuvant Temozolomide With or Without Hydroxychloroquine, Rapamycin for Newly Diagnosed Glioblastoma
This is a multi-center, phase II/III, open-label, randomized, parallel and standard chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to receive control treatment or study treatment. The primary objective of this trial is to evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival (OS) on newly diagnosed glioblastoma (GBM) patients.
Read the detailed description
After enrollment, subjects' previous tumor block used for glioblastoma diagnosis that is consented to provide during the study period will be sent to a central laboratory for the assessment of MGMT status. Moreover, subjects will be randomized in either Control or Study arm at Visit 2. Subjects in Control arm will receive a standard chemoradiation. However, subjects in Study arm will receive a standard chemoradiation in combination with concurrent JP001 in whole study period. During the study, a sufficient amount of investigational products will be supplied to subjects in study groups until next scheduled visits. Subjects will self-administer investigational product orally with water at approximately the same time in each day. Subjects should fast for a minimum of 2 hours prior to any doses of JP001 and/or Temozolomide and then fast for another 1 hour after taking JP001 and/or Temozolomide. During and at the end of treatment, subjects will be evaluated for efficacy and safety parameters. Moreover, there will be a Follow-up visit for safety 4 weeks after the End-of-Treatment visit. If a subject is early withdrawn from the study, the End-of-Treatment visit should be arranged and all assessments assigned in this visit should be performed. The Safety Follow-up visit for early withdrawn subjects could be either clinic visit or telephone contact. If withdrawn subjects refuse to perform Follow-up visit, the Follow-up visit is allowed to cancel. For subjects who completed or discontinued study treatment, assessment of survival status will be performed every 8 weeks by telephone contact until death, study end (last subject last visit; the last subject needs to be followed at least 30 months), or study termination by Sponsor. Survival information will be recorded in the medical source and CRF. If subjects are lost to follow-up or refuse to receive the assessment of survival status, the investigator will record the last date subjects known to be alive in the medical source and case report form.
- Conditions
- Glioblastoma
- Being tested
- CCRT, Temozolomide, Siroquine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRTRadiation
CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks).
TemozolomideDrug
Also called Chemotherapy
Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles.
SiroquineDrug
Also called JP001
- Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle).
- Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed.
| Study group | Role | What they receive |
|---|---|---|
| Radiation,Temozolomide | Active comparator | 1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks).
2. Rest Phase: Rest for 4 weeks.
3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles.
4. Maintenance Phase: No maintenance treatment until disease progression confirmed. Receives: Radiation: CCRT; Drug: Temozolomide |
| Radiation,Temozolomide,Siroquine(JP001) | Experimental | 1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks) + Daily JP001 (2 tablets once a day for 6 weeks).
2. Rest Phase: Daily JP001(2 tablets/day) for 4 weeks.
3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle).
4. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed. Receives: Radiation: CCRT; Drug: Temozolomide; Drug: Siroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time.
All subjects will be followed until study end (the date of last subject last visit; the last subject need to be followed at least 30 months) or death, whichever comes first; OS defined as the time from the date of Randomization to the date of death or last follow-up.
Measured: 120 weeks
Secondary outcomes (9)
Progression-free survival time
All subjects will be followed until study end or disease progression confirmed, whichever comes first; PFS defined as the time from the date of Randomization to the date of disease progression, death or last follow-up.
Measured: 120 weeks
OS rate at 1 year.
OS defined as the time from the date of Randomization to the date of death or last follow-up.
Measured: 1 year
PFS rate at 1 year.
PFS defined as the time from the date of Randomization to the date of disease progression, death or last follow-up.
Measured: 1 year
The time and rate of OS in different RPA class.
Measured: 120 weeks
The time and rate of PFS in different RPA class.
Measured: 120 weeks
Objective response rate.
Defined as the proportion of subjects who were confirmed completed response or partial response determined by RANO criteria.
Measured: 120 weeks
Changes in score of EORTC QLQ-C30
Measured: 120 weeks
Changes in score of EORTC QLQ-BN20.
Measured: 120 weeks
Changes in grade of ECOG performance status.
Measured: 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start11 Oct 2018
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnpro Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008148
- Sponsor's protocol ID
- JP001-GM-001
- Status last verified
- May 2021
- First submitted
- 23 Dec 2016
- Last updated
- 11 May 2021
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II/III Trial of Radiotherapy Plus Concomitant and Adjuvant Temozolomide With or Without Hydroxychloroquine, Rapamycin for Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03008148
- Acronym / sponsor ID
- JP001-GM-001
- Conditions
- Glioblastoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Johnpro Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- 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 multi-center, phase II/III, open-label, randomized, parallel and standard chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to receive control treatment or study treatment. The primary objective of this trial is to evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival (OS) on newly diagnosed glioblastoma (GBM) patients.
Detailed description
After enrollment, subjects' previous tumor block used for glioblastoma diagnosis that is consented to provide during the study period will be sent to a central laboratory for the assessment of MGMT status. Moreover, subjects will be randomized in either Control or Study arm at Visit 2. Subjects in Control arm will receive a standard chemoradiation. However, subjects in Study arm will receive a standard chemoradiation in combination with concurrent JP001 in whole study period. During the study, a sufficient amount of investigational products will be supplied to subjects in study groups until next scheduled visits. Subjects will self-administer investigational product orally with water at approximately the same time in each day. Subjects should fast for a minimum of 2 hours prior to any doses of JP001 and/or Temozolomide and then fast for another 1 hour after taking JP001 and/or Temozolomide. During and at the end of treatment, subjects will be evaluated for efficacy and safety parameters. Moreover, there will be a Follow-up visit for safety 4 weeks after the End-of-Treatment visit. If a subject is early withdrawn from the study, the End-of-Treatment visit should be arranged and all assessments assigned in this visit should be performed. The Safety Follow-up visit for early withdrawn subjects could be either clinic visit or telephone contact. If withdrawn subjects refuse to perform Follow-up visit, the Follow-up visit is allowed to cancel. For subjects who completed or discontinued study treatment, assessment of survival status will be performed every 8 weeks by telephone contact until death, study end (last subject last visit; the last subject needs to be followed at least 30 months), or study termination by Sponsor. Survival information will be recorded in the medical source and CRF. If subjects are lost to follow-up or refuse to receive the assessment of survival status, the investigator will record the last date subjects known to be alive in the medical source and case report form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation,Temozolomide | Active comparator | Radiation: CCRT, Drug: Temozolomide1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks). 2. Rest Phase: Rest for 4 weeks. 3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles. 4. Maintenance Phase: No maintenance treatment until disease progression confirmed. |
| Radiation,Temozolomide,Siroquine(JP001) | Experimental | Radiation: CCRT, Drug: Temozolomide, Drug: Siroquine1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks) + Daily JP001 (2 tablets once a day for 6 weeks). 2. Rest Phase: Daily JP001(2 tablets/day) for 4 weeks. 3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle). 4. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects with histologically proven newly diagnosed case of GBM (WHO grade IV) and treatment-naive (chemotherapy and radiotherapy) for GBM. Diagnosis must be made by stereotactic biopsy or surgical excision, either partial or complete within 3 months prior to Visit 1.
- Subject's RPA class is class III, IV or V.
- Subjects with stereotactic biopsy or brain surgery must be suited for or will be scheduled for CCRT followed by Temozolomide treatment, the standard treatment recommended by institutes and fulfilled the reimbursement guideline of National Health Insurance Administration.
- Subjects must have recovered from the effects of surgery, post-operative infection, and other complications prior to Visit 1. Study treatment must be performed > 3 weeks and ≤ 8 weeks after craniotomy. Ventricular fluid reservoir or Ventriculo-Peritoneal shunting tube is allowed to keep.
- A diagnostic contrast-enhanced MRI of the brain must be performed postoperatively within 28 days prior to Visit 2 (Day 1).
Key exclusion criteria (19 listed)
- Other invasive malignancy. However, subject with other invasive malignancy that have been disease-free more than or equal to 10 years and deemed no need for anti-cancer treatments can be recruited. Subjects with noninvasive malignancy, including carcinoma in situ of the breast, non-melanomatous skin cancer and cervix carcinoma in situ can be recruited if disease-free and treatment free more than or equal to 3 years.
- Metastases detected beyond the cranial vault.
- Subjects with the following history:
- Subjects are currently receiving any anti-rejection medicine or Hydroxychloroquine sulfate for rheumatoid arthritis.
- Subjects with severe and active co-morbidity, defined as follows:
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 |
|---|---|---|
| CCRTCCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks). | Radiation | Radiation,Temozolomide, Radiation,Temozolomide,Siroquine(JP001) |
| TemozolomideAlso: ChemotherapyTemozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles. | Drug | Radiation,Temozolomide, Radiation,Temozolomide,Siroquine(JP001) |
| SiroquineAlso: JP0011. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle). 2. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed. | Drug | Radiation,Temozolomide,Siroquine(JP001) |
Primary outcome
Overall survival time.
Time frame: 120 weeks
All subjects will be followed until study end (the date of last subject last visit; the last subject need to be followed at least 30 months) or death, whichever comes first; OS defined as the time from the date of Randomization to the date of death or last follow-up.
9 secondary outcomes
Progression-free survival time
Time frame: 120 weeks
OS rate at 1 year.
Time frame: 1 year
PFS rate at 1 year.
Time frame: 1 year
The time and rate of OS in different RPA class.
Time frame: 120 weeks
The time and rate of PFS in different RPA class.
Time frame: 120 weeks
Objective response rate.
Time frame: 120 weeks
Changes in score of EORTC QLQ-C30
Time frame: 120 weeks
Changes in score of EORTC QLQ-BN20.
Time frame: 120 weeks
Changes in grade of ECOG performance status.
Time frame: 120 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CCRT, Temozolomide and Siroquine in people with Glioblastoma, run by Johnpro Biotech, Inc. at 2 sites in Taiwan.
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 19 inclusion and 19 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Kwan-Hwa Chi (886-2-28332211 ext. 2274, M006565@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time. (time frame: 120 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 11 May 2021; AzTrials last refreshed its copy on 26 Oct 2026.