A Phase 2 clinical trial to assess the safety and efficacy of ACT001 in combination with whole brain radiation therapy (WBRT) for participants with brain metastases from solid tumours.
A Phase 2, open label, multicentre study assessing the safety and efficacy of ACT001 in combination with whole brain radiation therapy (WBRT) for brain metastases from solid tumours.
Accendatech Au Pty Ltd
20 participants
Oct 20, 2021
Interventional
Conditions
Summary
This study will evaluate the safety and tolerability of ACT001 in combination with standard of care whole brain radiation therapy for patients with metastatic brain cancer (cancer that has spread to the brain from another body part). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with secondary brain metastases (cancer lesions that have spread to the brain) from solid tumours including non-small cell lung cancer, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers, and you are eligible to undergo whole brain radiation therapy. Study details Participants will be asked to take 4 oral capsules of the study drug-ACT001 twice a day for up to 18 weeks. Standard care whole brain radiation therapy sessions will be scheduled to start 2 weeks after the first dose of ACT001, participants will continue to self-administer the daily doses of ACT001 until the end of the 18 week study period. During the study participants will be asked to attend a study clinic to report any unexpected side effects they experience during the study, and to complete quality of life questionnaires. Additional doses of ACT001 will be given to participants during these visits so that they can continue to self-administer the drug at home. All participants who are enrolled in this study will be asked to undergo a pre-treatment MRI, followed by two post-treatment MRIs at week 10 and week 18. It is hoped this research will demonstrate that ACT001 is safe and effective in treating patients with metastatic brain cancer, and is able to protect healthy cells during whole brain radiation therapy.
Eligibility
Inclusion Criteria14
- Patients with secondary brain metastases from solid tumours including NSCLC, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers. Definitive diagnosis of the primary site tumour by histology/cytology or molecular pathology;
- Participants that are assessed by the investigator to be suitable for WBRT;
- At least 1 measurable lesion according to RANO-BM criteria (verified by the radiologist and clinician), with a diameter of the lesion should be >/=10mm < /=40 mm;
- No previous history of abnormal bleeding and coagulation function International Normalised Ratio (INR) < /= 2;
- Age >/= 18 years
- Normal organ function (Absolute Neutrophil Count (ANC) >/=1.5 × 109/L, lymphocyte count >/= 0.5×109/L, platelet count >/= 75×109/L, Haemoglobin (Hb) >/= 10 g/dl; total Bilirubin < /= 1.5 x upper limit of normal (ULN); Alanine Aminotransferase (ALT) and Aspartate aminotransferase (AST) < /= 2.5 x ULN [if liver metastases are present < /= 5.0 x ULN]; plasma creatinine < /= 1.5 x ULN; QTc < 450 ms [males], < 470 ms [females];
- Life expectancy of at least 6 months
- Female participants must also fulfill the following criteria before enrolment can be considered: • Of non-childbearing potential, defined as:
- Previous hysterectomy or bilateral oophorectomy,
- or Previous bilateral tubal ligation,
- or Menopause (total cessation of menses for >/= 1 year).
- Of childbearing potential, but serum pregnancy test was negative during screening (within 7 days prior to the first dose of the investigational drug.) and agrees to employ contraceptive measures (such as intrauterine device, contraceptive drugs, or condoms) that are medically recognized before enrolment and during the study until 30 days after the last dose of the investigational drug.
- Male patients who are sexually active must agree to employ barrier contraceptive measures or complete abstinence.
- Agrees to sign the informed consent form before study enrolment.
Exclusion Criteria17
- Past history of brain radiotherapy.
- Participants with uncontrollable infection (systemic infection within 4 weeks prior to enrolment).
- Suffered from malignancies other than the primary tumour within 5 years prior to screening (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ).
- Participants previously diagnosed with small cell lung carcinoma (SCLC) with brain metastases
- Participants requiring continuous administration of hematopoietic factors (including granulocyte colony-stimulating factor, macrophage colony-stimulating factor) or platelet transfusion to maintain platelet count and absolute neutrophil count.
- Participants with severe heart disease before enrolment, such as unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association Class > II) or stroke (except for lacunar infarction).
- Patients with hypertension that cannot be controlled by drugs (systolic blood pressure over or equal to 160 mmHg, diastolic blood pressure over or equal to 100 mmHg after taking anti-hypertensive medications).
- Patients who are unable to take the drug orally or have malabsorption syndrome.
- Presence of epilepsy and/or elevated intracranial pressure that is refractory to drugs.
- Uncontrollable spinal cord compression
- Active cerebral haemorrhage in CT/MRI examinations.
- Known allergy to ACT001 or similar compounds or any component in the ACT001 formulation.
- Patients who received other anti-tumour treatment for brain metastases of solid tumours within 4 weeks prior to ACT001 treatment, such as chemotherapy, biologic therapy or targeted therapy, immunotherapy, radiotherapy, or electric field therapy.
- Toxicity caused by past anti-tumour treatment that has not been resolved, which is defined as: Toxicity that did not resolved to Grade < 2 according to CTCAE V 5.0 criteria (except for alopecia, alkaline phosphatase, and gamma-glutamyl transferase (GGT). Stable toxicity may be allowed after discussion with the investigator and sponsor.
- Pregnant or lactating women.
- Patients who participated in other clinical trials within 4 weeks prior to screening.
- Other reasons that are deemed unsuitable for participation in this trial by the investigator
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Interventions
An open label study using 400 milligrams (mg) of ACT001 oral capsule taken twice daily (total dose 800mg per day) in combination with standard of care whole brain radiation therapy in the setting of brain metastases from solid tumours including metastases from: Non Small Cell Lung Carcinoma (NSCLC), breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers. Drug return will be used to monitor adherence 400mg of ACT001 will be administered orally, twice a day, for 2 weeks (14 days) prior to commencement of Whole Brain Radiation Therapy (WBRT), and continue the study drug until the end of Week 18 (study drug will be taken for up to 126 days total if patient maintains good health and does not require additional follow on therapy post-WBRT).
Locations(1)
View Full Details on ANZCTR
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ACTRN12621000093886