Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Aged at least 20 years

• Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist

• At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST

• World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

• Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)

Exclusion Criteria:

• Clinically significant abnormalities of glucose metabolism as defined by any of the following:

• Diagnosis of diabetes mellitus type I or II (irrespective of management)

• Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)

• Glycosylated haemoglobin (HbA1C) >6.5%

• Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment

• Inadequate bone marrow reserve or organ function

• Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection

• With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment