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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)

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)

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221837
Enrollment
Unknown
Registered
2012-06-21
Start date
2012-06-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : AZD6244 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026