Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
1 - 17
Clinical summary
Summary
The purpose of this study is to estimate the maximum tolerated dose of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors.
Conditions
This trial is treating people with advanced cancers with ALK gene alterations
Eligibility
Inclusion
- Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
- Age ≥ 12 months and < 18 years
- The tumor must carry a genetic alteration of ALK
- Patients must have evaluable or measurable disease.
- Karnofsky performance status score ≥ 60% for patients > 12 years of age; Lansky score ≥ 50% for patients ≤ 12 years of age.
Exclusion
- Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
- Inadequate end organ function as defined by specified laboratory values
- Body surface area (BSA) < 0.35 m2
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LDK378 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
- Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
- Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
- History of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
- History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
- Medications with a known risk of prolongation of QT interval
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific Title
A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (Other ID's: CLDK378X2103, 2012-002074-31)
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