Solid TumoursPhase 1NCT03315091
Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours
A Phase 1 study testing Treatment A - AZD1775 administered under fasted conditions and Treatment B - AZD1775 administered under fed conditions. in people with Solid Tumours, run by AstraZeneca at 7 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumours
- What is being tested?
- Treatment A - AZD1775 administered under fasted conditions and Treatment B - AZD1775 administered under fed conditions.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 29 Sep 2017to 5 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study patients should fulfil the following criteria:
- Read and understand the informed consent form (ICF) and given written informed consent prior to any study procedures.
- Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
- Any prior palliative radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1.
- Baseline laboratory values within 7 days of study treatment initiation:
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- Absolute neutrophil count (ANC) ≥1500/μL.
- Haemoglobin ≥9 g/dL.
- Platelets ≥100,000/μL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if known hepatic metastases.
- Serum bilirubin within normal limits (WNL) or ≤1.5 x ULN in patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome.
- Serum creatinine ≤1.5 x ULN, or measured creatinine clearance (CrCl) calculated by Cockcroft-Gault method ≥45 mL/min (confirmation of creatinine clearance is only required when creatinine is >1.5 x ULN) CrCl (glomerular filtration rate) = (140-age) x (weight/kg) x Fa (72 x serum creatinine mg/dL)
- where F = 0.85 for females and F = 1 for males
- Female patients who are not of childbearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures that are in during screening (or consent), for the duration of the study, and for 1 month after treatment stops, and who are not breastfeeding, and who have a negative serum or urine pregnancy test prior to the start of study treatment.
- Male patients should be willing to use barrier contraception (ie, condoms) for the duration of the study and for 3 months after study treatment discontinuation
- Female or male patients ≥18 years.
- Patient should be able to adequately consume a high-fat meal as prescribed in Treatment B.
- Willingness and ability to comply with the study and the follow-up procedures.
- For inclusion in the optional genetic component of the study for all the patients:
- Provision of informed consent for genetic research. If a patient declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in the CSP, as long as all the eligibility criteria are met.
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study centre).
- Previous enrolment or randomisation and received study treatment in the present study. Patients can, however, be re-screened if the reason for the screen failure no longer exists.
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or haemorrhage for at least 2 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrolment.
- Use of any anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first administration of AZD1775. For drugs for which 5 half lives is ≤21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required.
- No other anticancer-therapy (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is to be permitted while patient is receiving study treatment. Patients on LHRH analogue treatment for more than 6 months are allowed entry into the study and may continue at the discretion of the Investigator.
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- Patients suffering from conditions which are likely to adversely affect gastrointestinal motility and/or transit (for example, diarrhoea, vomiting or nausea, gastroparesis, irritable bowel syndrome and malabsorption) or patients with gastrointestinal resection (eg, partial or total gastrectomy) likely to interfere with absorption of study treatment.
- Major surgical procedures ≤28 days of beginning study treatment, or minor surgical procedures ≤7 days. No waiting period required following port-a-cath placement or other central venous access placement.
- Grade >1 toxicities from prior therapy, according to the Common Terminology Criteria for Adverse Events (CTCAE), excluding alopecia or anorexia.
- Patient has an inability to swallow oral medications. Note: Patient may not have a percutaneous endoscopic gastrostomy tube or be receiving total parenteral nutrition.
- Patients who are not non-smokers or light smokers (no more than 5 cigarettes per day) and who cannot abstain from smoking from 2 weeks prior to the first administration of AZD1775 until after the last PK sample collection in Period 2.
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of AZD1775.
- Patient has had prescription or non-prescription drugs or other products known to be sensitive to cytochrome P450 (CYP)3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last administration of AZD1775. Co administration of aprepitant or fosaprepitant during this study is prohibited
- Patient has had adjustments to prescription or non-prescription drugs or other products known to be weak inhibitors and/or inducers of CYP3A4 within 1 week prior to the first administration of AZD1775.
- Herbal preparations taken within 7 days of study entry. However, in the case of St John's wort, patients cannot have taken this herbal preparation 21 days prior to first administration of AZD1775.
- Patients who have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc) within 7 days of first administration of AZD1775.
- Patients who are dependent on a medication which could adversely affect gastrointestinal motility or transit (for example: diphenoxylate, [loperamide], metoclopramide, cisapride, tegaserod, erythromycin). Note that use of loperamide is permitted during the study for treatment of diarrhoea Narcotics that are not in the list of prohibited medications are allowed.
- Patients who cannot withhold antacids for 6 hours or H2-antagonists (cimetidine, ranitidine, famotidine, nizatidine) for 48 hours.
- Patients unable to fast for up to 14 hours.
- Patients with type 1 diabetes mellitus.
- Any known hypersensitivity or contraindication to AZD1775 or to the components thereof.
- Any of the following cardiac diseases currently or within the last 6 months as defined by the New York Heart Association ≥ Class 2.
- Unstable angina pectoris.
- Congestive heart failure.
- Acute myocardial infarction.
- Conduction abnormality not controlled with pacemaker or medication.
- Significant ventricular or supraventricular arrhythmias (patients with chronic rate controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
- AZD1775 should not be given to patients who have a history of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected. AZD1775 has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.
- Patients with QT interval (specifically QTc calculated using the Fridericia formula [QTcF] >450 ms/male and >470 ms/female) obtained from 3 electrocardiograms (ECGs) 2 to 5 minutes apart at study entry, or congenital long QT syndrome.
- Pregnant or lactating female patients.
- Serious, symptomatic active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.
- Active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Any of the following is regarded as a criterion for exclusion from the optional pharmacogenetic part of the study:
- Previous bone marrow transplant.
- Non-leukocyte depleted blood product within 120 days of the genetic sample collection.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Netherlands3 sites
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV
Research Site
Maastricht, 6229 HX
United Kingdom2 sites
Research Site
Glasgow, G12 0YN
Research Site
Manchester, M20 4BX
About this study
Official title: 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
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.
Read the detailed description
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).
- Conditions
- Solid Tumours
- Being tested
- Treatment A - AZD1775 administered under fasted conditions, Treatment B - AZD1775 administered under fed conditions.
- Keywords
- Pharmacokinetics, WEE1 inhibitor, food effect, safety assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A - AZD1775 administered under fasted conditionsDrug
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 B - AZD1775 administered under fed conditions.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 (Fasted-Fed) | Experimental | 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. Receives: Drug: Treatment A - AZD1775 administered under fasted conditions; Drug: Treatment B - AZD1775 administered under fed conditions. |
| Treatment sequence 2 (Fed-Fasted) | Experimental | 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. Receives: Drug: Treatment A - AZD1775 administered under fasted conditions; Drug: Treatment B - AZD1775 administered under fed conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to infinity for AZD1775
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
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Area under the plasma concentration-time curve from time zero to the time "t" (AUC0-t) of the last quantifiable concentration for AZD1775
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
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Cmax: maximum plasma drug concentration for AZD1775
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
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Secondary outcomes (13)
tmax,: time to reach maximum plasma concentration for AZD1775
To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
λz: Elimination rate constant for AZD1775
To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Apparent clearance following oral administration for AZD1775
To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
t½,: terminal half-life for AZD1775
To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Apparent volume of distribution for AZD1775
To characterise the PK of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours
Measured: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3)
To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Complete physical examination including performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status criteria.
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.
Measured: Until 30 days following the final dose of AZD1775
Pulse Rate (beats/min)
To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Evaluation of Haematology Parameters (Haemoglobin, Leukocyte and Leukocyte counts, Red blood cell count, Haematocrit and Platelet Count)
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.
Measured: Until 30 days following the final dose of AZD1775
Electrocardiogram (ECG) - A 12-lead safety ECG (paper ECG printout of 10 seconds for Investigator review)
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.
Measured: Until 7 days following the final dose of AZD1775
Blood Pressure (mm Hg)
To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Body Temperature (°C)
To assess the safety and tolerability of a single dose of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Evaluation of Clinical Chemistry Parameters (Albumin, Alanine Transaminase, Aspartate Transaminase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, Glucose, Total protein, Chloride, Potassium, Sodium, Urea nitrogen)
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.
Measured: Until 30 days following the final dose of AZD1775
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start29 Sep 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Lone Ottesen, MD, Study director, AstraZenecaHenk Verheul, MD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315091
- Sponsor's protocol ID
- D6014C00005
- Status last verified
- Apr 2018
- First submitted
- 28 Sep 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03315091
- Acronym / sponsor ID
- D6014C00005
- Conditions
- Solid Tumours
- Keywords
- Pharmacokinetics, WEE1 inhibitor, food effect, safety assessments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 (Fasted-Fed) | Experimental | Drug: Treatment A - AZD1775 administered under fasted conditions, Drug: Treatment B - AZD1775 administered under fed conditions.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. |
| Treatment sequence 2 (Fed-Fasted) | Experimental | Drug: Treatment A - AZD1775 administered under fasted conditions, Drug: Treatment B - AZD1775 administered under fed conditions.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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Read and understand the informed consent form (ICF) and given written informed consent prior to any study procedures.
- Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
- Any prior palliative radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1.
- Baseline laboratory values within 7 days of study treatment initiation:
Key exclusion criteria (35 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study centre).
- Previous enrolment or randomisation and received study treatment in the present study. Patients can, however, be re-screened if the reason for the screen failure no longer exists.
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or haemorrhage for at least 2 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrolment.
- Use of any anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first administration of AZD1775. For drugs for which 5 half lives is ≤21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A - AZD1775 administered under fasted conditionsPremedication 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. | Drug | Treatment sequence 1 (Fasted-Fed), Treatment sequence 2 (Fed-Fasted) |
| Treatment B - AZD1775 administered under fed 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. | Drug | Treatment sequence 1 (Fasted-Fed), Treatment sequence 2 (Fed-Fasted) |
Primary outcome
Area under the plasma concentration-time curve from zero to infinity for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
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
Area under the plasma concentration-time curve from time zero to the time "t" (AUC0-t) of the last quantifiable concentration for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
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
Cmax: maximum plasma drug concentration for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
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
13 secondary outcomes
tmax,: time to reach maximum plasma concentration for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
λz: Elimination rate constant for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Apparent clearance following oral administration for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
t½,: terminal half-life for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Apparent volume of distribution for AZD1775
Time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose
Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3)
Time frame: Until 30 days following the final dose of AZD1775
Complete physical examination including performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status criteria.
Time frame: Until 30 days following the final dose of AZD1775
Pulse Rate (beats/min)
Time frame: Until 30 days following the final dose of AZD1775
Evaluation of Haematology Parameters (Haemoglobin, Leukocyte and Leukocyte counts, Red blood cell count, Haematocrit and Platelet Count)
Time frame: Until 30 days following the final dose of AZD1775
Electrocardiogram (ECG) - A 12-lead safety ECG (paper ECG printout of 10 seconds for Investigator review)
Time frame: Until 7 days following the final dose of AZD1775
Blood Pressure (mm Hg)
Time frame: Until 30 days following the final dose of AZD1775
Body Temperature (°C)
Time frame: Until 30 days following the final dose of AZD1775
Evaluation of Clinical Chemistry Parameters (Albumin, Alanine Transaminase, Aspartate Transaminase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, Glucose, Total protein, Chloride, Potassium, Sodium, Urea nitrogen)
Time frame: Until 30 days following the final dose of AZD1775
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Ottesen, MD study director
AstraZeneca
Henk Verheul, MD principal investigator
Amsterdam UMC, location VUmc
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A - AZD1775 administered under fasted conditions and Treatment B - AZD1775 administered under fed conditions. in people with Solid Tumours, run by AstraZeneca at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from zero to infinity for AZD1775 (time frame: Blood samples are collected on Day 1 of each treatment period at pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours post AZD1775 dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.