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Not yet recruiting NCT07643870

Human ADME Study of [14C]-AZD1390

Phase I Interventional Advanced Solid Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZD1390.
Who it may be relevant to
Registry conditions: Advanced Solid Malignancies. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies

Overview

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

Detailed description

On Day 1, participants will receive one dose of \[14C\]-AZD1390 . Participants will be confined to the study site until Day 8.

Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.

Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.

Interventions

  • Drug AZD1390
    single dose

Primary outcome measures

  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
  • The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Time frame: 6 Weeks]
Secondary outcome measures (12)
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • The phamrmacokinetic(s) of AZD1390 metabolite [Time frame: 6 weeks]
  • Metabolic profiling following single oral dose of AZD1390 [Time frame: 6 weeks]
  • The safety of a single dose of AZD1390 [Time frame: 6 weeks]
  • The safety of a single dose of AZD1390 [Time frame: 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 2 centers
  • Research Site — Guildford
  • Research Site — Liverpool

Identifiers

NCT: NCT07643870 · D6940C00006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗