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To assess the PK of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours in either a fed or fasted condition.

Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules. Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fasted conditions. The drug class of AZD1775 is Wee-1 kinase inhibitor.

Treatment A - AZD1775 administered under fasted conditions

Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules.

Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fed conditions.

The drug class of AZD1775 is Wee-1 kinase inhibitor.

Treatment B - AZD1775 administered under fed conditions.

Lone Ottesen, MD

Henk Verheul, MD

The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.

This is a Phase I, open-label, randomised, 2-period crossover design study in patients with advanced solid tumours.

The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules).In addition single dose safety and tolerability data will be gathered.

Patients will be screened within 28 days of Day 1 of the first treatment period (Period 1). Patients will take part in 2 randomised treatment sequences each separated by a washout period of at least 5 and no more than 14 days.

During Period 1, prior to administration of the first dose of study treatment, each patient will be randomised to 1 of 2 treatment sequences (Fasted-Fed or Fed-Fasted) to receive a single oral dose of 300 mg AZD1775 in each of the 2 treatment periods as follows:

* Fasted (Treatment A): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).
* Fed (Treatment B): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).

Pharmacokinetic and safety assessments will be obtained for up to 72 hours post-dose in each treatment period.

On completion of the study (ie, after collection of 72-hour PK sample and safety in period 2) patients will be evaluated per current assessments for their eligibility and interest to enrol into the open-label continued treatment access study (D6014C000007).

Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours

A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients With Advanced Solid Tumours

To investigate the effect of food on the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours

To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours

To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.

To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. If new or aggravated physical findings imply deterioration compared with baseline, the finding will be reported as an Adverse Event.

Laboratory tests will be performed by an accredited laboratory. Deterioration of haematology laboratory values as compared to baseline will be reported as Adverse Events if they fulfill any of the Serious Adverse Events criteria or are the reason for discontinuation of the study treatment unless clearly due to the progression of disease under study. If deterioration in a laboratory value is associated with clinical signs and symptoms, the sign or symptom will be reported as an AE and the associated laboratory result will be considered as additional information.

To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. The Investigator will judge the overall interpretation as normal or abnormal. If abnormal, it will be decided as to whether or not the abnormality is clinically significant or not clinically significant.

Laboratory tests will be performed by an accredited laboratory. Deterioration of clinical chemistry values as compared to baseline will be reported as Adverse Events if they fulfil any of the Serious Adverse Events criteria or are the reason for discontinuation of the study treatment unless clearly due to the progression of disease under study.

If deterioration in a laboratory value is associated with clinical signs and symptoms, the sign or symptom will be reported as an AE and the associated laboratory result will be considered as additional information.

Spots Global Cancer Trial Database for pharmacokinetics, wee1 inhibitor, food effect, safety assessments