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

AstraZeneca39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Malignancy Advanced Solid Tumor

Interventions

AZD5363DRUG

Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Chūōku, Japan

Outcomes

Primary Outcomes

To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally

To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies

Time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive

Secondary Outcomes

To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.

To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies. A dose will be considered non-tolerated and dose escalation will cease if 2 or more of up to 6 evaluable patients experience a DLT at a dose level. Six evaluable patients are required to determine the MTD

Time frame: once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)

To characterise the pharmacokinetics parameters Cmin

To characterise the pharmacokinetics parameters Cmin of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies

Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.

To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Data from ClinicalTrials.gov

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