Data

LDE225 A stratified multi-arm Phase 2 study evaluating the efficacy and safety of LDE225 in patients with advanced/metastatic sarcomas

Australia and New Zealand Sarcoma Association(ANZSA)

Dataset description

This dataset includes: Data on 46 patients with metastatic or unresectable sarcoma. Dosage information, disease progression, adverse events, imaging, lab results, medical history, questionnaires and logs of adverse events. Demographic data available: year of birth.

Date Information

Issued from 2023
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Source Study

Trial acronym

Not available

Trial ID

ACTRN12612000533897

Purpose

Treatment

Phase

Phase 2

Funding

Commercial sector/Industry,Novartis

Scientific enquiries

Ms Linda Cowan

Brief Summary

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 ....
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Key Inclusion Criteria

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 ....
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Key Exclusion Criteria

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 ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    46

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Sarcoma

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

LDE225; 4 x 200mg capsule once daily, orally; until disease progression

Comparison

Control group Uncontrolled

None

Outcomes

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.

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

De-identified IPD data collected throughout the study

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

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.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au