A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
- Conditions
- eoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080221837
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
- Patients who have overall good general conditions.
- Patients who have at least one lesion that can be accurately assessed by imaging.
- Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
- Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
- Patients with brain metastases or spinal cord compression.
- Patients with significant abnormal ECG findings.
- Patients with evidence of severe or uncontrolled systemic disease.
- The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
- Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method