uveal menaoma
Conditions
Interventions
Phase 1 with LXS196 and LXS196 in combination with HDM201.
Sponsors
Novartis B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Male or female patients *18 years of age, *Metastatic histologically or cytologically confirmed uveal melanoma with pathologic confirmation that is judged to be progressive in the opinion of the treating physician., *Willingness to provide newly obtained tumor tissue at baseline and on treatment unless contraindicated by medical risk in the opinion of the treating physician., *Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as >10 mm with CT scan. , *ECOG performance status * 1, Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: *Malignant disease other than that being treated in this study. Exceptions are described in section 5.2., *Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Treated brain metastases must have been stable for at least 1 month., *Impaired cardiac function or clinically significant cardiac diseases including history or presence of ventricular tachyarrhythmias or any uncontrolled arrhythmia., *Patients who are receiving treatment with medications that cannot be discontinued prior to study entry and that are considered to be any of the following:, -known and possible risk for QT prolongation, -known to be strong inducers or inhibitors of CYP3A4/5, -known to be inducers or inhibitors of P-gp, -known to be substrates of CYP3A4/5 and P-gp with a narrow therapeutic Index, *Patients with abnormal laboratory values, defined as any of the following:, -AST or ALT > 3 times ULN, AST or ALT > 5 times ULN for patients with liver metastases., -Total bilirubin > 1.5 x ULN, except for patients with Gilbert*s syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN., -Absolute neutrophil count (ANC) * 1.5 x 10e9/L (1500/mm3)., -Platelets * 100 x 10e9/L (100,000/mm3)., -Hemoglobin (Hgb) * 90 g/L (9 g/dL)., Other protocol-defined exclusion criteria may apply., Update AM3: - Creatinine > 1.5x ULN
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the preliminary antitumor activity of LXS196 alone or LXS196 in combination with HDM201 To characterize the pharmacokinetic profile of LXS196 alone or LXS196 in combination with HDM201 To assess the pharmacodynamic effect of LXS196 alone or LXS196 in combination with HDM201 | — |
Primary
| Measure | Time frame |
|---|---|
| To characterize the safety and tolerability of LXS196 alone or LXS196 in combination with HDM201 and to identify the MTD and/or Recommended dose for expansion (RDE). | — |
Countries
Netherlands
Outcome results
None listed