A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of MLN8237 in Japanese Subjects with Advanced Solid Tumors
- Conditions
- Advanced solid tumor
- Registration Number
- JPRN-jRCT2080221283
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Major inclusion criteria include the following:
1) Patients must have a diagnosis of a malignant solid tumor that is histologically or cytologically confirmed.
2) Patients with advanced solid tumor who are refractory to standard therapy, or for which no standard therapy is available.
3) Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Major exclusion criteria include the following:
1) Prior treatment with Aurora kinase inhibitors
2) Prior transplantation of allogeneic bone marrow, stem cells, or other organs
3) Patients with diagnosed brain metastases which requires treatment or symptomatic brain metastases
4) Major surgery within 14 days prior to enrollment or not yet recovered from prior major surgery.
5) Serious infection or infection that requires intravenous antibiotics within 14 days prior to enrollment.
6) Simultaneously diagnosed with or treated for another malignancy, or having a clinical history of primary malignancy in another organ(s)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method