Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Dose EscalationSafetyPreliminary EfficacyAdvanced Solid TumorsMetastatic Breast CancerAdvanced Pancreatic AdenocarcinomaMetastatic Colorectal CancerRecurrent Glioblastoma MultiformeGastric CancerGastroesophageal Junction CancerTriple Negative Metastatic Breast CancerHormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer
Interventions
DRUG

LDE225

DRUG

BKM120

Trial Locations (23)

2610

Novartis Investigative Site, Wilrijk

3050

Novartis Investigative Site, Parkville

20133

Novartis Investigative Site, Milan

27710

Duke University Medical Center Duke - Baker, Durham

33612

H. Lee Moffitt Cancer Center & Research Institute Moffitt 4, Tampa

45147

Novartis Investigative Site, Essen

55905

Mayo Clinic - Rochester Division of Hematology, Rochester

60126

Novartis Investigative Site, Ancona

75251

Texas Oncology Midtown Texas Oncology, Dallas

78246

Sammons Cancer Center - Texas Oncology SC-2, Dallas

84103

University of Utah / Huntsman Cancer Institute Huntsman, Salt Lake City

90048

Cedars Sinai Medical Center SC, Los Angeles

94101

University of California San Francisco UCSF (SC), San Francisco

97210

Northwest Cancer Specialists Northwest Cancer, Portland

97404

Willamette Valley Clinical Studies Williamette Valley Cancer, Eugene

02215

Dana Farber Cancer Institute Dana SC, Boston

19111-2497

Fox Chase Cancer Center FCCC, Philadelphia

77030-4009

University of Texas/MD Anderson Cancer Center SC-3, Houston

T6G 1Z2

Novartis Investigative Site, Edmonton

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

G12 0YN

Novartis Investigative Site, Glasgow

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY