Skip to main content
OpenTrials
Completed

NCT Number: NCT01605916

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms, Advanced Solid Malignancies Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Cancer, Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Non-small Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Fukuoka, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD6244

Drug

Tablet Oral bid

Other names: Selumetinib (AZD6244)

Primary outcomes

  1. Cmax of Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

  2. Tmax of Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

  3. AUC(0-12) of Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib

  4. Cmax of N-desmethyl Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

  5. Tmax of N-desmethyl Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

  6. AUC(0-12) of N-desmethyl Selumetinib After Single Dose

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib

  7. Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

  8. Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

  9. AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib

  10. Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

  11. Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

  12. AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

Secondary outcomes

  1. Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib

  2. Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib

  3. AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 25, 2012
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.