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Adavosertib

Enzyme Inhibitors

Patients will receive a single administration of \[14C\]adavosertib as an oral solution on Day 1.

Patients will receive a single administration of \[14C\]Adavosertib as an oral solution on Day 1.

[14C]Adavosertib

This is a non-randomised study in patients with advanced solid malignancies

The aim is to recruit approximately 8 patients with a minimum number of 4 pharmacokinetics (PK) evaluable patients.

Each patient will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 8. Patients will receive a single administration of \[14C\]adavosertib as an oral solution on Day 1. During this study, whole blood, plasma, urine, faeces, and vomit samples (if presented) will be collected at various time points to characterise the absorption, distribution, metabolism, excretion and PK of adavosertib.

The duration of the residential period will be evaluated following treatment of the first patient and may be adjusted to ensure recovery of at least 90% of the total radioactivity following the dose of \[14C\]adavosertib and/or until less than 1% of dose is recovered in urine and/or faeces within a 24-hour period.

Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib

A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients With Advanced Solid Tumours

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 mass balance of total radioactivity, including the routes and rates of elimination following a single oral dose \[14C\]adavosertib.

Assessment of renal clearance of adavosertib, including the routes and rates of elimination following a single oral dose \[14C\]adavosertib.

Assessment of Cmax of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUClast of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of tmax of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of λz of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of t½λz of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of CL/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of MRTinf of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of Vss/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of Vz/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf plasma adavosertib:Total plasma radioactivity ratio following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf Blood:Plasma Ratio total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of unchanged adavosertib following a single oral dose of \[14C\]adavosertib.

Assessment of CLR of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

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

Parexel

AstraZeneca

Symptoms and General Pathology

All Conditions

Neoplasms

Substance Related Disorders

Rare Diseases

Syndrome

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

All subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.

500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.

500 mg [14C]-LX1606

Doug Fleming, MD

To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects

Lexicon Pharmaceuticals

Antineoplastic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met.

After completion of Part I, patients with a deleterious BRCA mutation will have the option to participate in Part II by receiving 600 mg BID rucaparib tablets orally in 28 day cycles until disease progression, unacceptable toxicity, death, or discontinuation for other reasons

Each dosage unit consists of a hard gelatin capsule filled with cold rucaparib camsylate and \[14C\]-rucaparib camsylate salt. Each capsule contains approximately 150 mg rucaparib (free base weight) and approximately 35 µCi of \[14C\]-rucaparib. Each patient will ingest four capsules in the fasted state for a total dose of 600 mg rucaparib (free base weight) with approximately 140 µCi of \[14C\]-rucaparib

C-14 labeled Rucaparib

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

This is a Phase 1, open-label, non-randomized, mass balance study in patients with histologically or cytologically confirmed advanced solid tumors. Approximately 6 patients will be enrolled. The study will consist of 2 parts: a mass balance part (Part I) and a rucaparib treatment part (Part II).

Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. If the cumulative recovery of radioactivity exceeds 90% of the administered dose or if radioactivity in urine and feces is \< 1% of the administered dose over a 24 hour period on two consecutive days, as determined by quick counts.

In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

An Open-Label, Non-Randomized, Phase I Study to Assess the Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib in Patients With Advanced Solid Tumors

Response will be determined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and tumor markers per applicable criteria for a given tumor type

AUC from time zero to the last time point with concentration above the lower limit of quantitation (AUC0-last)

Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib	NCT05008913	Advanced Solid ...	[14C]Adavoserti...	18 Years - 130 Years	AstraZeneca
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males	NCT01932528	Carcinoid Syndr...	500 mg [14C]-LX...	30 Years - 65 Years	Lexicon Pharmaceuticals
Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib	NCT02986100	Solid Tumor	C-14 labeled Ru... Rucaparib	18 Years -	pharmaand GmbH
Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib	NCT05008913	Advanced Solid ...	[14C]Adavoserti...	18 Years - 130 Years	AstraZeneca
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males	NCT01932528	Carcinoid Syndr...	500 mg [14C]-LX...	30 Years - 65 Years	Lexicon Pharmaceuticals

Spots Global Cancer Trial Database for excretion

Every month we try and update this database with for excretion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for excretion

Every month we try and update this database with for excretion cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for excretion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.