NCT04946968

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

A Phase II Multi-Centre Study Evaluating the Efficacy of Dacomitinib for Patients With Epidermal Growth Factor Receptor (EGFR)-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expression or Other Novel Emerging Biomarkers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumours
• Non-small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Oral Dacomitinib	All subjects will receive the open-label Dacomitinib as tablets for oral self-administration on a continuous daily basis at a dose of 30 mg for one cycle. For subjects eligible for dose titration after Cycle 1, and after shared patient and investigator decision, these subjects will receive Dacomitinib 45 mg orally on a continuous daily basis.

Timeline

• Start date: 2021-08-24
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2021-07-01
• Last updated: 2025-06-11

Locations

2 sites across 1 country: Singapore