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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: Completed Phase 2 study of Advanced Endometrial Cancer, sponsored by Novartis Pharmaceuticals.
NCT01289041 is a Phase 2 study of Advanced Endometrial Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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 |
What the finished NCT01289041 record still lists
NCT01289041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01289041's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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