A phase I clinical study with investigational compound LTT462 in adult patients with specific advanced cancers

Phase 1

• Conditions: Adult and adolescent patients with advanced solid tumors harboring MAPK pathway alterations; MedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003614-24-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-11
• Study Completion: 2018-11-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

- 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.
- 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: 2
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

Exclusion Criteria

- 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 of 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