An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients with Advanced Solid Malignancies
- Conditions
- Advanced solid malignancies
- Registration Number
- JPRN-jRCT2031220106
- Lead Sponsor
- Yamaji Shigeyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
1. Signed written informed consent.
2. At least 18 years of age at the time of signing the ICF.
3. Histological or cytological confirmation of a solid, malignant tumor that is refractory to standard therapies or for which no standard therapies exist.
Measurable or non-measurable disease according to RECIST version 1.1.
4. Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status of 0 to 1 with no deterioration between screening and the first dose of the study treatment, and a minimum life expectancy of 12 weeks
5. Body weight >30 kg and no cancer-associated cachexia (e.g., common terminology criteria for adverse events [CTCAE] Grade 2 or worse weight loss over the past 3 months).
1. History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease >= 2 years before the first dose of the study drug and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
2. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting the study treatment, with the exception of alopecia and chemotherapy-related peripheral neuropathy.
3. Presence of life-threatening metastatic visceral disease, as judged by the investigator, uncontrolled central nervous system (CNS) metastatic disease. Patients with spinal cord compression and/or brain metastases may be enrolled if definitively treated (e.g., surgery or radiotherapy) and stable off steroids for at least 4 weeks prior to start of the study treatment.
4. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV], surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
5. Diagnosis of ataxia telangiectasia.
6. Refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant stomach/bowel resection, with clinically significant sequelae that would preclude adequate dissolution/absorption of ceralasertib. Partial gastrectomy with preservation of gastric pyloric function and partial resection of the large intestine can be eligible, but inclusion of patients with gastric pylorus resection or patients with duodenum, jejunum or ileum resection requires discussion with the sponsor.
7. Past medical history of interstitial lung disease (ILD) / pneumonitis requiring steroid treatment or any evidence of clinically active ILD / pneumonitis or potential ILD / pneumonitis which is not excluded by the screening test.
8. Treatment with any of the following:
(a) Any investigational medicinal product or other systemic anticancer treatment within 4 weeks prior to the first dose of the study treatment, or within 8 weeks after immunotherapy or other long half-life antibody therapy, whichever is the most appropriate and as judged by the Investigator
Note: androgen-deprivation therapy is permitted for patients with prostate cancer
(b) The potent inducers or inhibitors of CYP3A within 2 weeks of the first dose of the study treatment; except for St. John's wort, which is 3 weeks.
(c) Prior exposure to an ATR inhibitor.
(d) Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of the study treatment
(e) Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of the study treatment.
9. Participation in any clinical research study involving treatment with any investigational drug, radiotherapy or surgery, except for the non-treatment phases of these studies, e.g., follow-up phase.
10. History of hypersensitivi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of subjects with dose-limiting toxicity, as defined in the protocol.<br>Safety and tolerability in terms of adverse events.
- Secondary Outcome Measures
Name Time Method