A multicenter, open label, phase 1 dose escalation study to evaluate the pharmacokinetics, safety, and tolerability of INC280 tablet formulation with food in patients with cMET dysregulated advanced solid tumors
- Conditions
- C-MET dependent solid tumors10027656
- Registration Number
- NL-OMON43009
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
* * 18 years of age.
* Cytopathologically or histolopathologically confirmed diagnosis of an advanced solid tumor harboring cMET dysregulation which has progressed despite standard therapy, or for which no standard therapy exists. See protocol page 30 for more details re cMET dysregulation.
* At least one measurable lesion.
* Adequate organ function. See protocol page 30-31 for more details.
* ECOG performance status (PS) of 0 or 1.
* Prior treatment with crizotinib, or any other cMET or HGF inhibitor.
* Known hypersensitivity to any of the excipients of INC280.
* Symptomatic central nervous system metastases. See protocol page 31 for more details.
* Clinically significant, uncontrolled heart diseases, including QTcF * 450 ms (male patients), * 460 ms (female patients) on the screening ECG. See protocol page 31 for more details.
* Treatment with strong and moderate inhibitors of CYP3A4 or strong inducers of CYP3A4.
* Treatment with medications mentioned in items 13-15 on page 32.
* Pregnant or nursing (lactating) women.
* Females and males not using adequate contraception. See protocol page 32-33 for more details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose Limiting Toxicity in the first 28 days of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK parameters, adverse events.</p><br>