GBMPhase 2/3NCT03758014
Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients
A Phase 2/3 study testing Chlorogenic acid for Injection and Lomustine in people with GBM, run by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd at 1 site in China.
Trial summary
The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GBM
- What is being tested?
- Chlorogenic acid for Injection and Lomustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2018to 30 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18;
- KPS ≥ 60;
- Recurrent GBM;
- Estimated lifetime ≥ 3 months；
- Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
- Volunteered for the phase 2 trial and sign the informed consent without protest.
Who cannot join
- Patients who have received the therapy of chemotherapy or radical radiotherapy within 1 month before enrollment;
- Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
- Patients who had received a therapy of another investigational drug within 1 month；
- Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
- Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 1 week before enrollment;
- Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；
Show all 18Show fewer
- Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count<80×10~9/L； 2)NEUT# count<1.5×10~9/L ；3)HGB count<90g/L；4)Total bilirubin >1.5 times of ULN；5)ALT/AST >1.5 times of ULN；
- History of drug abuse；
- Patients who was treated with Immunologic drugs（DC/CIK/CTL/PD-（L）1） in 3 months;
- Patients who are false progressers；
- Patients who can not be received MRI examination；
- Patients who had severe trauma or infectious diseases within 4 weeks；
- Patients who had cerebral stroke or Transient ischemic attack within 6 months；
- Patients who were performed important operations within 4 weeks；
- Uncontrollable psychopaths;
- Patients who had other advanced cancers within 5 years；
- Patients who had grade III or IV heart failure within 6 months；
- Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Wenbin Li
About this study
Official title: A Randomized, Control, Open-label, Multicenter, Phase II/III Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients
The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine.
Read the detailed description
Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation. After received the clinical trial approval issued by CFDA, Jiuzhang Biotech successfully finished the phase I clinical studies of CHA for injection in advanced GBM patients, focus on safety, PK, and preliminary efficacy evaluation.
The results of phase I data showed that CHA had good safety, the main adverse effect was induration, no other serious adverse effects. PK exhibited that CHA had a rapid metabolism character (t1/2 = 1-1.5 h). In addition, there were no accumulative side effects for long-term use. To the investigators' surprise, the preliminary efficacy evaluation was amazing, there were 1 case CR and 1 case PR. The median OS of grade IV GBM patients was 21.4 months in effective dose group, which was much better than that of the historical reported data.The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine .
- Conditions
- GBM
- Being tested
- Chlorogenic acid for Injection, Lomustine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorogenic acid for InjectionDrug
Also called CHA
Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation.
LomustineDrug
Also called CCNU
Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood-brain barrier. This property makes it ideal for treating brain tumors, which is its primary use.
| Study group | Role | What they receive |
|---|---|---|
| Chlorogenic Acid for Injection | Experimental | 3 mg/kg per day, injection for 28 days，5 weeks per circle; max. 8 circles Receives: Drug: Chlorogenic acid for Injection |
| Lomustine | Active comparator | 110 mg/m2 taken as a single oral dose every 6 weeks; max. 4 circles Receives: Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival（OS）
Measured: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
Secondary outcomes (5)
progress free survival(PFS)
Measured: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
disease control rate（DCR)
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine
objective response rate (ORR)
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine
Karnofsky score standard
Measured: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
Montreal Cognitive Assessment score standard
Measured: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start27 Nov 2018
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, Study director, Beijing Tian Tan Hospital，Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758014
- Sponsor's protocol ID
- LYS-GBM-01
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- 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 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Control, Open-label, Multicenter, Phase II/III Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients
- ClinicalTrials.gov ID
- NCT03758014
- Acronym / sponsor ID
- LYS-GBM-01
- Conditions
- GBM
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan J.Z. Bio-chemical Science and Technology Development Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 29 Nov 2018 (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.
The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine.
Detailed description
Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation. After received the clinical trial approval issued by CFDA, Jiuzhang Biotech successfully finished the phase I clinical studies of CHA for injection in advanced GBM patients, focus on safety, PK, and preliminary efficacy evaluation.
The results of phase I data showed that CHA had good safety, the main adverse effect was induration, no other serious adverse effects. PK exhibited that CHA had a rapid metabolism character (t1/2 = 1-1.5 h). In addition, there were no accumulative side effects for long-term use. To the investigators' surprise, the preliminary efficacy evaluation was amazing, there were 1 case CR and 1 case PR. The median OS of grade IV GBM patients was 21.4 months in effective dose group, which was much better than that of the historical reported data.The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorogenic Acid for Injection | Experimental | Drug: Chlorogenic acid for Injection3 mg/kg per day, injection for 28 days，5 weeks per circle; max. 8 circles |
| Lomustine | Active comparator | Drug: Lomustine110 mg/m2 taken as a single oral dose every 6 weeks; max. 4 circles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18;
- KPS ≥ 60;
- Recurrent GBM;
- Estimated lifetime ≥ 3 months；
- Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
Key exclusion criteria (18 listed)
- Patients who have received the therapy of chemotherapy or radical radiotherapy within 1 month before enrollment;
- Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
- Patients who had received a therapy of another investigational drug within 1 month；
- Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
- Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 1 week before enrollment;
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 |
|---|---|---|
| Chlorogenic acid for InjectionAlso: CHAChlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation. | Drug | Chlorogenic Acid for Injection |
| LomustineAlso: CCNULomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood-brain barrier. This property makes it ideal for treating brain tumors, which is its primary use. | Drug | Lomustine |
Primary outcome
Overall Survival（OS）
Time frame: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
5 secondary outcomes
progress free survival(PFS)
Time frame: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
disease control rate（DCR)
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine
objective response rate (ORR)
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine
Karnofsky score standard
Time frame: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
Montreal Cognitive Assessment score standard
Time frame: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- 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.
Wenbin Li study director
Beijing Tian Tan Hospital，Capital Medical University
1 site 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 Chlorogenic acid for Injection and Lomustine in people with GBM, run by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd at 1 site in China.
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 18 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 29 Nov 2018. 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 China. 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 Wenbin Li (8615301377998, neure55@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival（OS） (time frame: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine). 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 29 Nov 2018.