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 October 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01605916
First received: May 21, 2012
Last updated: October 22, 2014
Last verified: October 2014

May 21, 2012
October 22, 2014
June 2012
April 2015   (final data collection date for primary outcome measure)
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 ]
Investigation of the safety (grade and frequency of all adverse event) and tolerability of AZD6244 (75mg bd) + 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 up period. The follow-up period is defined as 28 days after AZD6244 and/or docetaxel is discontinued. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01605916 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
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)

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasms,
  • Metastatic Cancer,
  • Non-Small Cell Lung Cancer
  • Advanced Solid Malignancies
  • Drug: AZD6244
    Tablet Oral bid
  • Drug: Docetaxel
    IV once every 21 days
    Other Name: Taxotere
Experimental: AZD6244 with or without Docetaxel
AZD6244 with or without Docetaxel
Interventions:
  • Drug: AZD6244
  • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2015
April 2015   (final data collection date for primary outcome measure)

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.

Both
20 Years and older
No
Contact: Gabriella Mariani ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Clinical Study Information 800-236-9933
Japan
 
NCT01605916
D1532C00067
Not Provided
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP