drugset / Trial / NCT02640755
Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase
Non-randomizedParallel-groupOpen-labelOther
Summary
This Phase 1, open label, single centre, non-randomised study in patients with advanced solid malignancies consists of two parts: 1. Single Dose Period - will characterise the absorption, metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\]AZD2014 from the body 2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour activity of multiple doses of AZD2014 when given as a monotherapy or given in combination with paclitaxel or fulvestrant.
Timeline
- Start
- 2016-01-28
- Primary completion
- 2016-12-21
- Completion
- 2017-07-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Vistusertib | Small molecule | 50 mg | Oral |
| Subject | Vistusertib | Small molecule | 125 mg | Oral |