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NCT02260661 · ClinicalTrials.gov registry record · Phase 1
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02260661 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 20 participants.
The verdict
NCT02260661, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy. Part B follows the multiple ascending dose phase, additional patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose expansion phase. Part C is a second dose escalation phase in which post-menopausal patients with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in combination with fulvestrant. Part D follows the combination dose escalation phase of the study, additional postmenopausal patients with ER+/HER2 negative breast cancer with documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination dose-expansion phase at maximum tolerated dose or recommended phase II dose.
Interventions
- DRUG AZD8835
- DRUG AZD8835 in combination with fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02260661
The ClinicalTrials.gov registry entry for NCT02260661 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AZD8835 is the first listed.
NCT02260661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02260661 about?
NCT02260661 is a clinical study titled "Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours". First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy. Part B follows the multiple ascending dose phase, additional patients with tumors with document...
What is the current status of trial NCT02260661?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-11. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02260661?
The interventions under investigation include: AZD8835 (DRUG), AZD8835 in combination with fulvestrant (DRUG).
Who is sponsoring clinical trial NCT02260661?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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