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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor; Advanced Solid Malignancy

Treatments: Drug: AZD5363

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353781

D3610C00004

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

AZD5363

Experimental group

Description:

Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD)

Treatment:

Drug: AZD5363