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

Launched by ASTRAZENECA · May 13, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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