Trials / Completed
CompletedNCT01597388
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
Detailed description
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD2014 | Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week |
| DRUG | Fulvestrant | IM monthly after loading dose |
Timeline
- Start date
- 2012-05-08
- Primary completion
- 2016-08-04
- Completion
- 2026-01-13
- First posted
- 2012-05-14
- Last updated
- 2026-02-24
- Results posted
- 2018-10-17
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01597388. Inclusion in this directory is not an endorsement.