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

NCT04946968 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Singapore Translational Cancer Consortium

    collaborator UNKNOWN

  • Cancer Science Institute of Singapore

    collaborator UNKNOWN

  • Genome Institute of Singapore

    collaborator OTHER

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Daniel SW Tan · National Cancer Centre, Singapore

  • Boon Cher Goh · National University of Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946968 on ClinicalTrials.gov