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NCT01219699 · ClinicalTrials.gov registry record · Phase 1
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 221
- Enrollment target
NCT01219699 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 221 participants.
The verdict
NCT01219699, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 221 participants
- Enrollment target
Study Summary
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene
Interventions
- DRUG Fulvestrant
- DRUG BYL719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2010-10-05 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01219699
The ClinicalTrials.gov registry entry for NCT01219699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT01219699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01219699 about?
NCT01219699 is a clinical study titled "A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene". This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestra...
What is the current status of trial NCT01219699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 221 participants. The study started on 2010-10-05. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT01219699?
The interventions under investigation include: Fulvestrant (DRUG), BYL719 (DRUG).
Who is sponsoring clinical trial NCT01219699?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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