A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma
- Conditions
- uveal menaomacancer of the eye10030054
- Registration Number
- NL-OMON47593
- Lead Sponsor
- ovartis B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
*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.
*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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the safety and tolerability of LXS196 alone or LXS196 in<br /><br>combination with HDM201 and to identify the MTD and/or Recommended dose for<br /><br>expansion (RDE). </p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the preliminary antitumor activity of LXS196 alone or LXS196 in<br /><br>combination with HDM201<br /><br>To characterize the pharmacokinetic profile of LXS196 alone or LXS196 in<br /><br>combination with HDM201<br /><br>To assess the pharmacodynamic effect of LXS196 alone or LXS196 in combination<br /><br>with HDM201</p><br>