A phase I clinical study with investigational compound LTT462 in adult patients with specific advanced cancers
- Conditions
- Adult and adolescent patients with advanced solid tumors harboring MAPK pathway alterationsMedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003614-24-IT
- Lead Sponsor
- OVARTIS PHARMA SERVICES AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
-Patient (male or female) =12 years of age
- ECOG (Eastern Cooperative Oncology Group) performance status =1
- Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy
exists, is tolerated or appropriate.
-Patients must have a site of disease amenable to biopsy and be a
candidate for tumor biopsy. Patients must be willing to undergo a new
tumor biopsy at screening/baseline and during therapy.
- Patients must be willing to undergo study required biopsies.
- Presence of at least one measurable lesion according to RECIST v1.1.
- Documented MAPK Pathway alteration
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
-- Prior treatment with ERK inhibitors.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
- Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to
safety concerns or compliance with clinical study procedures.
- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the
duration of the study.
- Clinically significant cardiac disease
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize safety and tolerability of LTT462 and identify a recommended dose and regimen for future studies in adult and adolescent patients with advanced solid tumors harboring MAPK pathway alterations.;Secondary Objective: - To evaluate the preliminary anti-tumor activity of LTT462 <br>- To evaluate the pharmacokinetic (PK) profile of LTT462<br>- To assess the pharmacodynamic (PD) effect of LTT462<br>;Primary end point(s): Safety and tolerability as assessed by<br>incidence and severity of adverse events (AEs), dose interruptions, reductions and dose intensity<br>- Incidence and nature of dose limiting toxicities (DLTs) (dose escalation only);Timepoint(s) of evaluation of this end point: Cycle 1 day 1 until 30 days post study treatment (expected duration approximately 12 months)<br>1 cicle (28 days)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): For both parts: Overall response rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), and Progression Free Survival (PFS)<br>Plasma concentration and derived PK parameters of LTT462 (AuC, Cmax, Tmax and T1/2)<br>- For dose expansion part only:<br>Overall Survival (OS)<br>Changes from baseline of the PD marker DUSP6 in tumor tissue and in blood;Timepoint(s) of evaluation of this end point: At protocol defined timepoints (PK, PD and preliminary anti-tumor activity end point until the end of the study