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Wee-1 kinase inhibitor AZD1775

Phase 1

Solid Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 24, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Wee-1 kinase inhibitor AZD1775 · 1 trial · 1 indication

Phase 1 1
NCT03313557AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology StudiesSolid Tumors
COMPLETED48 Analytics
PHASE1COMPLETED
AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.3)
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.
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)
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)
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)
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
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.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Wee-1 kinase inhibitor AZD1775EXPERIMENTALTo 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.

Interventions

NameTypeDescription
Wee-1 kinase inhibitor AZD1775DRUGPatients 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.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 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 cl...

Countries:United StatesFranceNetherlandsUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about Wee-1 kinase inhibitor AZD1775

What is Wee-1 kinase inhibitor AZD1775 used for?

Wee-1 kinase inhibitor AZD1775 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for safety and tolerability in patients with solid tumors.

What does Wee-1 kinase inhibitor AZD1775 target?

Wee-1 kinase inhibitor AZD1775 targets the Wee-1 kinase, an enzyme involved in cell cycle regulation. By inhibiting this kinase, the drug may disrupt DNA damage repair processes in cancer cells. This mechanism is being explored as a potential therapeutic approach for solid tumors.

Who makes Wee-1 kinase inhibitor AZD1775?

Wee-1 kinase inhibitor AZD1775 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical trials for the treatment of solid tumors.

What phase is Wee-1 kinase inhibitor AZD1775 in?

Wee-1 kinase inhibitor AZD1775 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing clinical program is focused on assessing the safety and tolerability of the drug in patients with solid tumors.

What clinical trials is Wee-1 kinase inhibitor AZD1775 in?

Wee-1 kinase inhibitor AZD1775 has one completed clinical trial, NCT03313557, titled 'AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies.' This Phase 1 study enrolled 48 patients with solid tumors across the United States, France, Netherlands, and United Kingdom.

Is Wee-1 kinase inhibitor AZD1775 the same as AZD1775?

Yes, Wee-1 kinase inhibitor AZD1775 is also known as AZD1775. The drug is a small molecule being developed by AstraZeneca for the treatment of solid tumors. It is currently in Phase 1 clinical trials and remains an investigational agent.