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NCT01289041 · ClinicalTrials.gov registry record · Phase 2
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
A Phase 2 study of Advanced Endometrial Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT01289041 is a Phase 2 study of Advanced Endometrial Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT01289041, a Phase 2 study of Advanced Endometrial Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
Conditions Studied
Interventions
- DRUG BKM120
Study Locations (20)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Liège
- Novartis Investigative Site - Wilrijk
- Novartis Investigative Site - Le Mans
- Novartis Investigative Site - Lyon
Texas
- Texas Oncology, P.A. Austin - Bedford
- South Texas Oncology and Hematology, PA South Tex Onc - San Antonio
Ontario
- Novartis Investigative Site - Hamilton
- Novartis Investigative Site - Toronto
Arizona
- St. Joseph's Hospital & Medical Center St Joseph's - Phoenix
Arkansas
- Highlands Oncology Group Dept of Highlands Oncology Grp - Fayetteville
New Jersey
- Morristown Memorial Hospital MMH - Morristown
North Carolina
- Carolinas HealthCare Systems Blumenthal Cancer Center - Charlotte
Oklahoma
- University of Oklahoma Health Sciences Center OU Health - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01289041
The ClinicalTrials.gov registry entry for NCT01289041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 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 1 condition, with Advanced Endometrial Cancer appearing as the primary indexed condition, and to 1 intervention - of which BKM120 is the first listed.
NCT01289041 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Texas, Ontario.
Frequently Asked Questions
What is clinical trial NCT01289041 about?
NCT01289041 is a clinical study titled "BKM120 as Second-line Therapy for Advanced Endometrial Cancer". This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100...
What is the current status of trial NCT01289041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-02. Estimated completion is 2014-03.
What conditions does trial NCT01289041 study?
This clinical trial studies the following conditions: Advanced Endometrial Cancer.
What interventions are being tested in trial NCT01289041?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01289041?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01289041 being conducted?
This trial has 20 study locations across Arizona, Arkansas, New Jersey, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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