Overview

Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers

Status:
Not yet recruiting

Trial end date:
2026-07-01

Target enrollment:

Participant gender:

Summary

Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker. Subjects will receive open-label Dacomitinib as tablets for oral administration on a continuous daily basis at a dose of 30 mg for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects with >=G2 toxicity attributable to dacomitinib, will continue dacomitinib at 30 mg orally once daily. In subjects with <=G1 toxicity, investigator and subjects will make a shared decision for dose escalation of dacomitinib to 45 mg orally once daily or continuation of dacomitinib at 30 mg orally once daily. Subjects will then continue on therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurs first.

Phase:

Phase 2

Details

Lead Sponsor:

National Cancer Centre, Singapore

Collaborators:

Cancer Science Institute of Singapore
Genome Institute of Singapore
Singapore Translational Cancer Consortium