AzTrials
AzTrials

Recurrent GBMPhase 1/2NCT03234595

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma

A Phase 1/2 study testing Cerebraca wafer in people with Recurrent GBM, run by Everfront Biotech Co., Ltd. at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cerebraca Wafer (75 mg [(Z)-n-butylidenephthalide]) is designed for surgical combination to treat glioblastoma (GBM) diseases. High-grade glioma includes GBM (Grade IV, isocitrate dehydrogenase 1 [IDH1] wild-type) and anaplastic astrocytoma (Grade IV and Grade III, IDH1 mutation). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Recurrent GBM
What is being tested?
Cerebraca wafer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesTaiwan
Study dates
1 Nov 2017to 3 Sep 2024
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male, age ≥ 20 years old
  • Patient has diagnosed recurrent high grade glioma, including anaplastic astrocytoma and glioblastoma multiforme
  • Patients have enough cavity after glioma resection for planned number of wafer implantation (by Investigator's judgment)
  • Patients have unilateral single focus of tumor in cerebrum
  • Patients have the 1st time recurrence of glioma
  • Patients undergone standard therapy for their prior glioma episode; for patients with anaplastic astrocytoma, the prior standard therapy should include surgical resection, radiation and adjuvant temozolomide (or PCV [procarzine, lomustine and vincristine]; for patients with glioblastoma multiforme the prior standard therapy should include surgical resection, radiation and adjuvant temozolomide
Show all 29Show fewer
  • Patients with Karnofsky Performance Score (KPS) ≥ 50
  • Patients are recovered from toxicities from prior systemic therapies and have adequate hematopoietic function at screening and before using study medication
  • Absolute neutrophil count (ANC) ≥ 1,000 cells /mm3
  • Platelets ≥ 100,000 /mm3
  • Total white blood cell (WBC) ≥ 2,500 cells /mm3
  • Total bilirubin ≤ 2.5 mg/dL
  • AST ≤ 4 x ULN
  • ALT ≤ 4 x ULN
  • ALP ≤ 5 x ULN
  • Creatinine ≤ 2.0 mg/dL
  • GFR ≥ 30 ml/min/1.73m2
  • Patient with no or mild organ impairment
  • Patients who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms
  • Patients agrees not to use food supplementary or dietary that contains Angelica sinensis after Screening Visit to Day 21
  • All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after Cerebraca wafer treatment and TMZ treatment (whichever is longer) shown below.
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
  • Combination of any two of the following (a+b or a+c, or b+c):
  • Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
  • Phase IIa The inclusion criteria for Phase IIa is the same as in Phase I

Who cannot join

  • Phase I and IIa
  • Patient who has participated in other investigational studies within 4 weeks prior to receive Cerebraca wafer
  • Patient with known or suspected hypersensitivity to Cerebraca wafer, TMZ or the excipient
  • Patient has tumor that cannot be surgically removed without significantly affecting vital function
  • Patient's glioma locates in the area that is not suitable for Cerebraca wafer implantation
  • Patient has external-beam radiation therapy within 4 weeks before study entry
Show all 12Show fewer
  • Patient has other severe and/or life-threatening disease(s) with life expectancy less than 12 months
  • Patient has immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive.
  • Patient with medical, social or psychological factors interfering with compliance of the study
  • Patient has on-going moderate to severe organ impairment other than study indication that may confound the efficacy evaluation, safety evaluation or usage of TMZ
  • At Phase I, patient is planning to use strong cytochrome P450 modulator.
  • Female patients are lactating, pregnant, or planned to be pregnant

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Hualien Tzu Chi Hospital

    Hualien City

  • Taichung Veterans General Hospital

    Taichung

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Everfront Biotech Co., Ltd.

Cerebraca Wafer (75 mg [(Z)-n-butylidenephthalide]) is designed for surgical combination to treat glioblastoma (GBM) diseases. High-grade glioma includes GBM (Grade IV, isocitrate dehydrogenase 1 [IDH1] wild-type) and anaplastic astrocytoma (Grade IV and Grade III, IDH1 mutation). Among these, GBM is the most common and aggressive brain tumor. Patient suffering from GBM usually develops symptoms such as headaches, seizures, memory loss, and changes in behavior in its early phase. At later stages, patients may encounter loss of movement and sensation, language dysfunction, and cognitive impairments depending on location and size of the tumor. The average survival of recurrent GBM patients is 6 to 9 months regardless of the use of current available therapies.

The clinical trial aimed to evaluate the safety and efficacy profiles of Cerebraca Wafer plus adjuvant TMZ in patients with recurrent GBM. Additionally, the study sought to determine the maximum tolerated dose (MTD) of Cerebraca Wafers. This study specifically examined the safety of the intended dose of 6 wafers.

Read the detailed description
  • This is a first-in-human, open-label, one-arm, Phase I/IIa study to investigate the safety and efficacy of Cerebraca Wafer with adjuvant TMZ treatment in patients with recurrent high-grade glioma. Eligible participants are to receive Cerebraca Wafer implantation as well as TMZ treatment.
  • Phase I is a typical dose escalation study utilizing traditional 3+3 study design. There are 4 dose levels in this stage. DLT is to be assessed during the Phase I to evaluate the safety and tolerance of Cerebraca Wafer and to determine the MTD. Data and Safety Monitoring Board (DSMB) meetings are held before dose escalation and for MTD determination.
  • In Phase IIa, participants are to be enrolled for assessment of the efficacy and safety. The cavity surface after tumor removal is maximally covered by Cerebraca Wafer without exceeding the MTD defined in Phase I. Data collected from participants in Phase I receiving treatment as designed for Phase IIa are incorporated into Phase IIa to reduce the participant number. The study consists of 2 periods:
  1. Main Study Period (including Screening Visit [up to 30 days] and Contiguous and Intermitting Visits [overall 24 weeks])
  2. Extended Period (including Follow-up Visits [every 8 weeks])
Conditions
Recurrent GBM
Being tested
Cerebraca wafer
Keywords
Cerebraca Wafer, Recurrent high-grade glioma, Astrocytoma, Glioblastoma, IDH wild type, MGMT unmethylation (chemoresistance)
Medical subject headings
Glioblastoma, Glioma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cerebraca waferDrug

    Eligible patients will receive Cerebraca wafer implantation with adjuvant temozolomide (TMZ) for the safety and efficacy in this study. At Phase I, the MTD will be determined by DLT. At Phase IIa, up to 12 evaluable patients will be enrolled for the efficacy and safety of Cerebraca wafer implantation. At Phase IIa, the cavity surface after tumor removal will be maximally covered by Cerebraca wafer without exceeding the MTD defined at Phase I. Patients in Phase I receive treatment as designed for Phase IIa, the data will be incorporated into Phase IIa to reduce the patient number. The overall patient number in this study is therefore between 2 to 36 evaluable patients.

Study groups in NCT03234595
Study groupRoleWhat they receive
single armExperimentalThere is 1 treatment arm with 4 dose cohorts in Phase I and 1 treatment arm in Phase IIa.
Receives: Drug: Cerebraca wafer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose (MTD) of Cerebraca Wafer by dose limiting toxicity (DLT) in patients with recurrent high-grade glioma.

    MTD and DLT

    Measured: 2 year

  2. To evaluate the efficacy profiles of Cerebraca Wafer in patients with recurrent high-grade glioma.

    Overall survival (OS)

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start1 Nov 2017
  3. Primary completion30 Apr 2023
  4. Study completion3 Sep 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234595
Sponsor's protocol ID
EFBPOLZ20141120
Status last verified
Sep 2024
First submitted
25 Jul 2017
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cerebraca wafer in people with Recurrent GBM, run by Everfront Biotech Co., Ltd. at 3 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 29 inclusion and 12 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD) of Cerebraca Wafer by dose limiting toxicity (DLT) in patients with recurrent high-grade glioma. (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03234595.

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 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in