Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability (OAK)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancy,; Safety and Tolerability,; Tumour Response,; Pharmacokinetics, Pharmacodynamics,

Treatments: Drug: AZD5363

Study type: Interventional

Funder types: Industry

Identifiers

NCT01895946

D3610C00007

Details and patient eligibility

About

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Full description

This study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, AZD5363, in patients with advanced cancer . This study will investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.

Enrollment: 33 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: -

• Aged at least 18 years
• The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist
• The presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is suitable for repeated assessment
• Estimated life expectancy of more than 12 weeks

Exclusion Criteria: -

• Clinically significant abnormalities of glucose metabolism
• Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids)
• Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and Human Immunodeficiency Virus (HIV)
• Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures
• A bad reaction to AZD5363 or any drugs similar to it in structure or class

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Part A: Formulation Switch

Experimental group

Description:

AZD5363 tablet twice daily followed by AZD5363 capsule twice daily on an intermittent regimen (4 days on, 3 days off).

Treatment:

Drug: AZD5363

Drug: AZD5363

Part B: Food effect

Experimental group

Description:

AZD5363 tablet twice daily on an intermittent regimen (4 days on, 3 days off) with/without food on one occasion

Treatment:

Drug: AZD5363

Drug: AZD5363