Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT01576666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01576666
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 120 participants
Conditions and interventions
Conditions
- Dose Escalation
- Safety
- Preliminary Efficacy
- Advanced Solid Tumors
- Metastatic Breast Cancer
- Advanced Pancreatic Adenocarcinoma
- Metastatic Colorectal Cancer
- Recurrent Glioblastoma Multiforme
- Gastric Cancer
- Gastroesophageal Junction Cancer
- Triple Negative Metastatic Breast Cancer
- Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2012
- Primary completion
- Mar 31, 2015
- Completion
- Mar 31, 2015
- Last update posted
- Dec 18, 2020
2012 – 2015
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center SC | Los Angeles | California | 90048 | — |
| University of California San Francisco UCSF (SC) | San Francisco | California | 94101 | — |
| H. Lee Moffitt Cancer Center & Research Institute Moffitt 4 | Tampa | Florida | 33612 | — |
| Dana Farber Cancer Institute Dana SC | Boston | Massachusetts | 02215 | — |
| Mayo Clinic - Rochester Division of Hematology | Rochester | Minnesota | 55905 | — |
| Duke University Medical Center Duke - Baker | Durham | North Carolina | 27710 | — |
| Willamette Valley Clinical Studies Williamette Valley Cancer | Eugene | Oregon | 97404 | — |
| Northwest Cancer Specialists Northwest Cancer | Portland | Oregon | 97210 | — |
| Fox Chase Cancer Center FCCC | Philadelphia | Pennsylvania | 19111-2497 | — |
| Texas Oncology Midtown Texas Oncology | Dallas | Texas | 75251 | — |
| Sammons Cancer Center - Texas Oncology SC-2 | Dallas | Texas | 78246 | — |
| University of Texas/MD Anderson Cancer Center SC-3 | Houston | Texas | 77030-4009 | — |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City | Utah | 84103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01576666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01576666 live on ClinicalTrials.gov.