Investigate the Safety and Tolerability of AZD6244 + Docetaxel in Japanese Patients With Non-Small Cell Lung Cancer - Full Text View

Purpose

The objective 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 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.

Condition	Intervention	Phase
Neoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer	Drug: AZD6244 Drug: Docetaxel	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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) [ Time Frame: AEs will be collected throughout the study, from informed consent until the end of the follow ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the pharmacokinetics (Cmax, tmax, AUC) of AZD6244, metabolites and docetaxel when dosed together. [ Time Frame: Multiple PK samples from day 1 to day 12 after first dose of study drugs. ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Combination therapy AZD6244 plus Docetaxel	Drug: AZD6244 Tablet Oral bid Drug: Docetaxel IV once every 21 days Other Name: Taxotere

Detailed Description:

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)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605916

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Locations

Japan
Research Site	Recruiting
Nagoya, Aichi, Japan
Research Site	Recruiting
Kashiwa, Chiba, Japan
Research Site	Recruiting
Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Ian Smith, Medical Science Director	AstraZeneca
Principal Investigator:	Yuichiro Ohe, Medical Doctor	National Cancer Centre East
Principal Investigator:	Hideo Saka, Medical Doctor	National Hospital Organisation Nagoya Medical Centre
Principal Investigator:	Takashi Seto, Medical Doctor	National Hospital Organization Kyushu Cancer Center

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01605916 History of Changes
Other Study ID Numbers:	D1532C00067
Study First Received:	May 21, 2012
Last Updated:	March 11, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Cancer,
Tumour,
Metastatic,
Lung cancer,
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:

Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013