Not available
ACTRN12612000533897
Treatment
Phase 2
Commercial sector/Industry,Novartis
Ms Linda Cowan
The purpose of this study is to evaluate the efficacy and safety of LDE225 as a treatment for patients with metastatic sarcoma who can not be treated by surgery. Who is it for? You may be eligible for this study if you are aged 18 years or above, have a histologically confirmed diagnosis of metastatic or unresectable sarcoma with no known curative treatment options, and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial de .... Read more
1. At least 18 years of age at the time of study entry 2. All participants must have histologically confirmed metastatic or unresectable sarcoma, (a) with a strong preclinical rationale for Hh pathway activation. Cohort 1: Metastatic osteosarcoma Cohort 2: Metastatic or unresectable chondrosarcoma Cohort 3: An open cohort including other subtypes of patients for which there is a biological rationale, with a particular emphasis on patients with Ewing’s sarcoma, desmoplastic small round cell tumou .... Read more
1. Patients who have had any systemic cytotoxic/ biologic or investigational therapies within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry or who have not recovered from the side effects of such earlier therapy. 2. Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry 3. Concurrent use of any other anti-cancer therapies or study agents. 4. Prior treatment with a smoothened (Smo) antagonist, systemic LDE225, or other Hh pathway i .... Read more
No
Sample Size 46
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Sarcoma
Condition code Cancer
Intervention code Treatment: Drugs
LDE225; 4 x 200mg capsule once daily, orally; until disease progression
Control group Uncontrolled
None
Outcome: Achievement of complete response or partial response during the first 12 weeks of treatment or maintenance of stable disease until 12 weeks after commencement of treatment per RECIST 1.1 guidelines.Timepoint: At 12 weeks after treatment commencement.
yes
De-identified IPD data collected throughout the study
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis