Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
NCT01576666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2020-12-19
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).
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
Interventions
- DRUG
-
LDE225
- DRUG
-
BKM120
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmceuticals · Novartis Pharmceuticals
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
- Australia
- Belgium
- Canada
- Germany
- Italy
- Spain
- United Kingdom
Study Locations
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