Solid TumorsPhase 1NCT03313557
AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
A Phase 1 study testing Wee-1 kinase inhibitor AZD1775 in people with Solid Tumors, run by AstraZeneca at 14 sites in 4 countries.
Trial summary
Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Wee-1 kinase inhibitor AZD1775
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 27 Oct 2017to 17 May 2019
- 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 this study, patients must fulfil the following criteria:
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures.
- Female or male aged ≥18 years.
- Has completed 1 of the parent AZD1775 clinical pharmacology studies (ie, D6014C00002, D6014C00003, D6014C00004, D6014C00005, or D6014C00006) and in the Investigator's opinion will continue to benefit from treatment with AZD1775. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis.
- Any prior radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute effects prior to the start of study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
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- Baseline laboratory values within 7 days of study treatment initiation in the CA study:
- 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 or ≤1.5 x ULN in patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct bilirubin within normal limits 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 of non-childbearing potential and fertile women of childbearing potential (WoCBP) who agree to use adequate contraceptive measures that are in place during screening (or consent), for the duration of the study, and for 1 month after treatment stops; who are not breastfeeding; and who have a negative serum or urine pregnancy test prior to the start of study treatment.
- Male patients must be willing to use barrier contraception (ie, condoms) for the duration of the study and for 3 months after study treatment discontinuation.
- Willingness and ability to comply with the study and the follow-up procedures.
Who cannot join
- Patients must not enrol in this 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 and received study treatment in the present study. Patients can, however, be re-screened if the reason for the screen failure no longer exists.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
- Must not have received another systemic anti-cancer therapy in the interval following participation in the AZD1775 clinical pharmacology study and the start of treatment on the CA protocol.
- Not developed any clinical findings suggestive of brain metastasis. Patients continue to be neurological stable and remain off systemic corticosteroids following treatment of known brain metastases.
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- Did not tolerate AZD1775 in the parent study in the opinion of the Investigator.
- Where a course of palliative radiotherapy was indicated, the last fraction must have been delivered before the start of study treatment on the CA study.
- 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.
- Continue to be able to swallow oral medication, did not undergo placement of a percutaneous endoscopic gastrostomy tube and did not require total parenteral nutrition.
- Has had prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 between the parent study and entry into this CA study. Co administration of aprepitant or fosaprepitant during this study is prohibited.
- Has consumed herbal preparations between the parent study and entry into this CA study.
- Has consumed grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges between the parent study and entry into the CA study.
- 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.
- Patient with mean resting QTc interval (specifically QTc calculated using the Fridericia formula [QTcF]) >450 ms for males and >470 ms for females from 3 electrocardiograms (ECGs) performed within 2 to 5 minutes apart during screening, 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).
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States7 sites
Research Site
Bingham Farms, Michigan, 48025
Research Site
Cincinnati, Ohio, 45229
Research Site
Dallas, Texas, 75251
Research Site
Detroit, Michigan, 48202
Research Site
Greenville, South Carolina, 29605
Research Site
Lebanon, New Hampshire, 03756
Research Site
Providence, Rhode Island, 02903
Netherlands3 sites
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV
Research Site
Maastricht, 6202 AZ
United Kingdom2 sites
Research Site
Glasgow, G12 0YN
Research Site
Manchester, M20 4BX
About this study
Official title: An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.
Read the detailed description
This is an open-label, non-randomised study designed to provide continued access to AZD1775 for eligible patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of a once daily monotherapy regimen of AZD1775 in patients with advanced solid tumours.
All patients who completed 1 of the parent clinical pharmacology studies are eligible for this study after a washout period of at least 4 days (minimum duration defined in the parent study protocol) and meet the eligibility criteria specified in this protocol. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis.
During the study, patients will continue to receive AZD1775 as long as they are benefiting from treatment in the Investigator's opinion and do not meet any other discontinuation criteria.
- Conditions
- Solid Tumors
- Being tested
- Wee-1 kinase inhibitor AZD1775
- Keywords
- Continued access, safety assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wee-1 kinase inhibitor AZD1775Drug
Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Wee-1 kinase inhibitor AZD1775 | Experimental | To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours in patients who have previously completed 1 of the AZD1775 clinical pharmacology studies and not have met any requirements to permanently discontinue treatment with AZD1775. Receives: Drug: Wee-1 kinase inhibitor AZD1775 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3)
To assess the safety of AZD1775 following oral dosing of the capsule formulation 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 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, unless the findings are unequivocally due to disease progression.
Measured: Until 30 days following the final dose of AZD1775
Pulse Rate (beats/min)
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Blood Pressure (mm Hg)
To assess the safety and tolerability 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 AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Measured: Until 30 days following the final dose of AZD1775
Evaluation of Laboratory Parameters
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours; deterioration of haematology and clinical chemistry 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start27 Oct 2017
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT03313557
- Sponsor's protocol ID
- D6014C00007
- Status last verified
- Jun 2019
- First submitted
- 13 Oct 2017
- Last updated
- 24 Jun 2019
- 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 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
- ClinicalTrials.gov ID
- NCT03313557
- Acronym / sponsor ID
- D6014C00007
- Conditions
- Solid Tumors
- Keywords
- Continued access, safety assessments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 18 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.
Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.
Detailed description
This is an open-label, non-randomised study designed to provide continued access to AZD1775 for eligible patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of a once daily monotherapy regimen of AZD1775 in patients with advanced solid tumours.
All patients who completed 1 of the parent clinical pharmacology studies are eligible for this study after a washout period of at least 4 days (minimum duration defined in the parent study protocol) and meet the eligibility criteria specified in this protocol. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis.
During the study, patients will continue to receive AZD1775 as long as they are benefiting from treatment in the Investigator's opinion and do not meet any other discontinuation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wee-1 kinase inhibitor AZD1775 | Experimental | Drug: Wee-1 kinase inhibitor AZD1775To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours in patients who have previously completed 1 of the AZD1775 clinical pharmacology studies and not have met any requirements to permanently discontinue treatment with AZD1775. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures.
- Female or male aged ≥18 years.
- Has completed 1 of the parent AZD1775 clinical pharmacology studies (ie, D6014C00002, D6014C00003, D6014C00004, D6014C00005, or D6014C00006) and in the Investigator's opinion will continue to benefit from treatment with AZD1775. Patients who discontinue early from the parent study will be considered by the Sponsor and treating physician on a case-by-case basis.
- Any prior radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute effects prior to the start of study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
Key exclusion criteria (26 listed)
- Patients must not enrol in this 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 and received study treatment in the present study. Patients can, however, be re-screened if the reason for the screen failure no longer exists.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
- Must not have received another systemic anti-cancer therapy in the interval following participation in the AZD1775 clinical pharmacology study and the start of treatment on the CA protocol.
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 |
|---|---|---|
| Wee-1 kinase inhibitor AZD1775Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated. | Drug | Wee-1 kinase inhibitor AZD1775 |
Primary outcome
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
To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours
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
To assess the safety and tolerability 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, unless the findings are unequivocally due to disease progression.
Pulse Rate (beats/min)
Time frame: Until 30 days following the final dose of AZD1775
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Blood Pressure (mm Hg)
Time frame: Until 30 days following the final dose of AZD1775
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Body Temperature (°C)
Time frame: Until 30 days following the final dose of AZD1775
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
Evaluation of Laboratory Parameters
Time frame: Until 30 days following the final dose of AZD1775
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours; deterioration of haematology and clinical chemistry 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.
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 24 Jun 2019.
- 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
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wee-1 kinase inhibitor AZD1775 in people with Solid Tumors, run by AstraZeneca at 14 sites in 4 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 16 inclusion and 26 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, 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?
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). The study lists 6 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 24 Jun 2019.