Study identifier:D1532C00067
ClinicalTrials.gov identifier:NCT01605916
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Neoplasms,
Phase 1
No
AZD6244
All
33
Interventional
20 Years - 150 Years
Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Nov 2017 by AstraZeneca
AstraZeneca
-
The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.
The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 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). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated. The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.
Location
Location
Nagoya-shi, Japan
Location
Kashiwa-shi, Japan
Location
Fukuoka-shi, Japan
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) |
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