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Human ADME Study of [14C]-AZD1390

Not Yet RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Advanced Solid Malignancies

Interventions: AZD1390

Countries: United Kingdom

This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
* Predicted life expectancy ≥ 12 weeks,
* Adequate organ and marrow function,
* Creatinine clearance ≥ 50 mL/min,
* Regular bowel movements,
* No cancer-associated cachexia (weight loss).

Exclusion Criteria:

* History or presence of myopathy or raised CK \> 5 × ULN at screening,
* History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
* History or presence of clinically significant hepatic disease,
* History of epileptic disorder or any seizure history unrelated to tumour,
* History of MDS/AML or with features suggestive of MDS/AML,
* Predisposition to bleeding
* History of persisting (\> 2 weeks) severe cytopenia
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
* History of another primary malignancy
* Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
* Spinal cord compression or brain metastases for at least 4 weeks

Locations (2)

Guildford, United Kingdom
Liverpool, United Kingdom