Investigate the Safety and Tolerability of AZD6244 monotherapy or + Docetaxel in Japanese Patients with Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Study identifier:D1532C00067
ClinicalTrials.gov identifier:NCT01605916
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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)
Medical condition
Neoplasms,
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD6244
Sex
All
Actual Enrollment
33
Study type
Interventional
Age
20 Years - 150 Years
Date
Study Start Date: 01 Jun 2012
Primary Completion Date: 06 Apr 2015
Study Completion Date: 25 May 2015
Study design
Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selumetinib (AZD6244) 25 mg monotherapy | Drug: AZD6244 Tablet Oral bid Other Name: Selumetinib (AZD6244) |
| Experimental: Selumetinib (AZD6244) 50 mg monotherapy | Drug: AZD6244 Tablet Oral bid Other Name: Selumetinib (AZD6244) |
| Experimental: Selumetinib (AZD6244) 75 mg monotherapy | Drug: AZD6244 Tablet Oral bid Other Name: Selumetinib (AZD6244) |
| Experimental: Selumetinib (AZD6244) 75 mg + Doce Combination | Drug: AZD6244 Tablet Oral bid Other Name: Selumetinib (AZD6244) |
| Experimental: Selumetinib (AZD6244) 25 mg + Doce combination | Drug: AZD6244 Tablet Oral bid Other Name: Selumetinib (AZD6244) |
Contacts
Investigators
Principal Investigator
Ian Smith
AstraZeneca
