Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605916
• Other study ID #: D1532C00067
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2012
• Last updated: June 3, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.

Patients with histologically or cytologically confirmed advanced solid malignancies.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Cancer,
• Neoplasm Metastasis
• Neoplasms
• Neoplasms,
• Non-Small Cell Lung Cancer

Intervention

Drug:
• AZD6244
Tablet Oral bid
• Docetaxel
IV once every 21 days

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kashiwa-shi
Japan	Research Site	Nagoya-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the safety (grade and frequency of all adverse event) and tolerability of AZD6244 monotherapy or + Docetaxel in Japanese patients with Advanced Solid Malignancies or Non-Small Cell Lung Cancer (Stage IIIB-IV)		AEs will be collected throughout the study, from informed consent until the end of the follow	No
Secondary	Evaluation of the pharmacokinetics (Cmax, tmax, AUC) of AZD6244, metabolites and docetaxel when dosed together.		Multiple PK samples from day 1 to day 12 after first dose of study drugs.	No