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.

Phase 2

• Conditions: Metastatic Brain Cancer; Solid Tumours; Cancer - Brain

• Registration Number: ACTRN12621000093886
• Lead Sponsor: Accendatech Au Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Study Completion: 2022-08-09
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. 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;
2. Participants that are assessed by the investigator to be suitable for WBRT;
3. 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;
4. No previous history of abnormal bleeding and coagulation function International Normalised Ratio (INR) < /= 2;
5. Age >/= 18 years
6. 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];
7. Life expectancy of at least 6 months
8. 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.
9. Male patients who are sexually active must agree to employ barrier contraceptive measures or complete abstinence.
10. Agrees to sign the informed consent form before study enrolment.

Exclusion Criteria

1. Past history of brain radiotherapy.
2. Participants with uncontrollable infection (systemic infection within 4 weeks prior to enrolment).
3. 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).
4. Participants previously diagnosed with small cell lung carcinoma (SCLC) with brain metastases
5. 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.
6. 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).
7. 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).
8. Patients who are unable to take the drug orally or have malabsorption syndrome.
9. Presence of epilepsy and/or elevated intracranial pressure that is refractory to drugs.
10. Uncontrollable spinal cord compression
11. Active cerebral haemorrhage in CT/MRI examinations.
12. Known allergy to ACT001 or similar compounds or any component in the ACT001 formulation.
13. 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.
14. 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.
15. Pregnant or lactating women.
16. Patients who participated in other clinical trials within 4 weeks prior to screening.
17. Other reasons that are deemed unsuitable for participation in this trial by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified