LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Stopped early · Phase 2

Conditions studied: PTCH1 or SMO Activated Solid and Hematologic Tumors

In brief

The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study

Key facts

Study ID

NCT02002689

Run by

Novartis Pharmaceuticals

People needed

10

Starts

2014-02-01

Expected to finish

2015-03-01

Last updated by the study team

2016-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has confirmed diagnosis of a select solid tumor (except medulloblastoma, basal cell carcinoma and pancreatic adenocarcinoma) or hematological malignancy (except CML, ALL and AML).
• Patient has pre-identified tumor with a PTCH1 or SMO mutation.
• Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
• Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

You may not qualify if…

• Patients has received prior treatment with LDE225.
• Patients has neuromuscular disorders associated with elevated CK (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis
• Patients has primary CNS tumor or CNS tumor involvement
• Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Where it is running

• University of California Davis Cancer Center UC Davis Cancer (3) — Sacramento, California, United States
• Rocky Mountain Cancer Centers RMCC - Aurora — Greenwood Village, Colorado, United States
• Lurie Children's Hospital of Chicago Developmental Therapeutics — Chicago, Illinois, United States
• Minnesota Oncology Hematology, P.A. Southdate Medical Center — Minneapolis, Minnesota, United States
• Cleveland Clinic Foundation Cleveland Clinic (19) — Cleveland, Ohio, United States
• Sanford Research Sanford Health — Sioux Falls, South Dakota, United States
• Oncology Consultants Oncology Group — Houston, Texas, United States
• MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3) — Houston, Texas, United States
• Intermountain Medical Center Intermountain Healthcare — Murray, Utah, United States
• Seattle Cancer Care Alliance Skagit Valley Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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