A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies (OAK)

A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies (OAK) - OAK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40390

Enrollment

Registered

2013-08-16

Start date

2013-12-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid malignancies advanced solid tumours

Interventions

Twice daily dosing with AZD5363 following an intermittent schedule. Intermittent schedule: * the patient is dosed 4 days on, 3 days off AZD5263 treatment. * depending on emerging data the intermitten

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Provision of written informed consent . - 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 CT, MRI or plain X-ray and is suitable for repeated assessment. - Estimated life expectancy of more than 12 weeks.

Exclusion criteria

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 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.

Design outcomes

Primary

Measure	Time frame
Part A: to compare the PK exposure of a new AZD5363 tablet formulation with that of the AZD5363 capsule formulation in patients with advanced solid malignancies. Part B: to explore the effect of a standardised meal on the PK exposure of a new tablet formulation of AZD5363 in patients with advanced solid malignancies.	—

Secondary

Measure	Time frame
* Safety and tolerability. * Tumour evaluation according to RECIST 1.1. * AZD5363 pharmacokineticsk/pharmacodynamics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)