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NCT01576666 · ClinicalTrials.gov registry record · Phase 1
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
A Phase 1 study of Gastric Cancer and Advanced Solid Tumors, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT01576666: Completed Phase 1 study of Gastric Cancer and Advanced Solid Tumors, sponsored by Novartis Pharmaceuticals.
NCT01576666 is a Phase 1 study of Gastric Cancer and Advanced Solid Tumors that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 120 participants, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576666, a Phase 1 study of Gastric Cancer and Advanced Solid Tumors, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).
Primary Outcome
Dose Limiting Toxicities (DLTs) during the first 6 weeks (42 days) of the combination treatment of LDE225 and BKM120.
Conditions Studied
Interventions
- DRUG LDE225
- DRUG BKM120
Study Locations (20)
Texas
- Texas Oncology Midtown Texas Oncology - Dallas
- Sammons Cancer Center - Texas Oncology SC-2 - Dallas
- University of Texas/MD Anderson Cancer Center SC-3 - Houston
California
- Cedars Sinai Medical Center SC - Los Angeles
- University of California San Francisco UCSF (SC) - San Francisco
Oregon
- Willamette Valley Clinical Studies Williamette Valley Cancer - Eugene
- Northwest Cancer Specialists Northwest Cancer - Portland
Other
- Novartis Investigative Site - Wilrijk
- Novartis Investigative Site - Essen
Florida
- H. Lee Moffitt Cancer Center & Research Institute Moffitt 4 - Tampa
Massachusetts
- Dana Farber Cancer Institute Dana SC - Boston
Minnesota
- Mayo Clinic - Rochester Division of Hematology - Rochester
North Carolina
- Duke University Medical Center Duke - Baker - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT01576666 record still lists
NCT01576666 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (62% lower).
The record links to 10 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions - of which LDE225 is the first listed.
NCT01576666 names 20 study sites across 15 states, led by Texas, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT01576666 about?
NCT01576666 is a clinical study titled "Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors". The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with c...
What is the current status of trial NCT01576666?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2012-07. Estimated completion is 2015-04.
What conditions does trial NCT01576666 study?
This clinical trial studies the following conditions: Gastric Cancer, Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Gastroesophageal-junction Cancer.
What interventions are being tested in trial NCT01576666?
The interventions under investigation include: LDE225 (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01576666?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01576666 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01576666's enrollment target sits among peer trials
120 74th of 153 higher than 79 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer 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.
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