A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) 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)
20 Years
N/A
Both
Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer
Trial Information
A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) 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)
A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244
(Selumetinib) 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)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Investigate the safety (grade and frequency of all adverse event) and tolerability of AZD6244 (25mg bid or 50mg bid or 75mg bid) + Docetaxel (60mg/m2 or 75mg/m2 iv) in Japanese patients with Non-Small Cell Lung Cancer (Stage IIIB-IV)
Outcome Time Frame:
AEs will be collected throughout the study, from informed consent until the end of the follow
Safety Issue:
No
Principal Investigator
Ian Smith, Medical Science Director
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D1532C00067
NCT ID:
NCT01605916
Start Date:
June 2012
Completion Date:
April 2014
Related Keywords:
- Neoplasms,
- Metastatic Cancer,
- Non-Small Cell Lung Cancer
- Cancer,
- Tumour,
- Metastatic,
- Lung cancer,
- Non-Small Cell Lung Cancer
- Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
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