All Drugs and Chemicals

Adavosertib

Enzyme Inhibitors

Patients with advanced solid tumours will receive Adavosertib once daily for 5 days followed by 2 days off for 2 weeks out of a 21-day cycle.

Patients will receive Adavosertib orally.

The purpose of this study is to allow continued adavosertib treatment of patients with advanced solid tumours participating in the adavosertib clinical pharmacology studies and to assess the continued safety and tolerability of adavosertib for patients enrolled in adavosertib clinical pharmacology studies (hereafter referred to as the 'parent studies') who continue to use the therapy

Patients will be screened within 14 days of Day 1 of the treatment period. During screening, patients will undergo an appropriate washout period after the last dose of adavosertib in the parent clinical pharmacology study before receiving the first dose of adavosertib in this study.

Patients will continue to receive adavosertib as long as they are benefiting from treatment in the investigator's opinion and do not meet any other discontinuation criteria.

The number of patients who enroll is dependent on the number of patients who complete the parent studies, and who tolerate adavosertib in the parent study.

The anticipated total duration of the study is approximately 3 years.

A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours Enrolled in Adavosertib Clinical Pharmacology Studies

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Assessment of the safety and tolerability of adavosertib following oral dosing of the capsule formulation in patients with advanced solid tumours

Parexel

AstraZeneca

Gastrointestinal Agents

Antineoplastic Agents

Lactitol

Spartalizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

All subjects in all combination will be entered in one arm

PDR001

Novartis Pharmaceuticals

Caitlin Rogers

Catherine Shu

Ashley Drokin

Rom Leidner

Funda Meric-Bernstam

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours	NCT04949425	Advanced Solid ...	Adavosertib	18 Years - 130 Years	AstraZeneca
A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours	NCT04949425	Advanced Solid ...	Adavosertib	18 Years - 130 Years	AstraZeneca
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments	NCT04058756	Advanced Solid ...	PDR001	18 Years -	Novartis
A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours	NCT04949425	Advanced Solid ...	Adavosertib	18 Years - 130 Years	AstraZeneca

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