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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Metastatic Cancer,; Neoplasms,; Advanced Solid Malignancies; Non-Small Cell Lung Cancer

Treatments: Drug: AZD6244

Study type: Interventional

Funder types: Industry

Identifiers

NCT01605916

D1532C00067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 5 patient groups

Selumetinib (AZD6244) 25 mg

Experimental group

Description:

monotherapy

Treatment:

Drug: AZD6244

Selumetinib (AZD6244) 50 mg

Experimental group

Description:

monotherapy

Treatment:

Drug: AZD6244

Selumetinib (AZD6244) 75 mg

Experimental group

Description:

monotherapy

Treatment:

Drug: AZD6244

Selumetinib (AZD6244) 75 mg + Doce

Experimental group

Description:

Combination

Treatment:

Drug: AZD6244

Selumetinib (AZD6244) 25 mg + Doce

Experimental group

Description:

combination

Treatment:

Drug: AZD6244