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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01605916
First received: May 21, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) [ 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 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD6244 with or without Docetaxel
AZD6244 with or without Docetaxel
Drug: AZD6244
Tablet Oral bid
Drug: Docetaxel
IV once every 21 days
Other Name: Taxotere

Detailed 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.

  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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com

Locations
Japan
Research Site Recruiting
Fukuoka-shi, Japan
Research Site Recruiting
Kashiwa-shi, Japan
Research Site Not yet recruiting
Nagoya-shi, 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: June 6, 2014
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 July 20, 2014