A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BEY1107, Temozolomide.
- Who it may be relevant to
- Registry conditions: Glioblastoma Multiforme. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patient with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Overview
This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Detailed description
In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.
Interventions
- Drug BEY1107
Administer twice daily, PO, 4-week continuous dose. - Combination product Temozolomide
Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.
Primary outcome measures
- Maximum Tolerated Dose(MTD) [Time frame: From baseline up to disease progression, approximately 4 weeks]
- Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I. [Time frame: From baseline up to disease progression, approximately 48 weeks]
Secondary outcome measures (5)
- Disease control rate(DCR) [Time frame: From baseline up to disease progression, approximately 48 weeks]
- Progression-free survival(PFS) rate at 6 months [Time frame: From baseline up to 6 months]
- Pharmacokinetic(PK) of maximum serum Concentration (Cmax) [Time frame: From baseline up to 4 weeks post-dose]
- Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) [Time frame: From baseline up to 4 weeks post-dose]
- Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) [Time frame: From baseline up to 4 weeks post-dose]
Eligibility criteria
Inclusion criteria
- Adult males and females aged over 19 years or older at the time of Informed Consent.
- Diagnosed with GBM according to the World Health Organization(WHO) criteria.
- Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
- For Subjects using corticosteroids, those who do not need escalation within at least 2 weeks prior to administration of Investigational Product(IP) and on a stable dose.
- Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
8 Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
9\. Subjects who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.
Exclusion criteria
- Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- Subjects who have not recovered from the toxicity of the prior anticancer therapy.
- Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
- Subjects with a history of other malignancy except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ, papillary thyroid cancer or early gastric cancer.
- Subjects with a genetic problem(eg. Galactose intolerance).
- Subjects with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
- Subjects with hypersensitivity to dacarbazine (DTIC).
- Subjects who have the cardiovascular disease as of screening.
- Active hepatitis B, C or HIV positive.
- Patients with acute or severe infection.
- Subjects who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
- Subjects who had been administered other IP within 4 weeks prior to screening.
- Patients with inadequate bone marrow, kidney and liver function.
- Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
- Subjects with life expectancy of less than 12 weeks by the investigator.
- Subjects determined by the investigator to be ineligible for participation in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT05769660 · BEY-2021-02