Phase 1 Open-Label Study of DCC-2618 in Patients with Adv Malignancies
Research type
Research Study
Full title
A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients with Advanced Malignancies
IRAS ID
229068
Contact name
Jama Pitman
Contact email
Sponsor organisation
Deciphera Pharmaceuticals, LLC
Eudract number
2016-001324-60
Duration of Study in the UK
2 years, 2 months, 2 days
Research summary
This study will determine the safety and tolerability of DCC-2618 in adults with advanced malignancies. DCC-2618 is being studied as a possible treatment for patients with advanced malignancies driven by a gene called proto-oncogene which produces the protein called tyrosine-protein kinases. Mutations in this gene are involved in the presence of solid cancerous tumours (advanced malignancies). DCC-2618 block the activity of receptor tyrosine kinases and/or their targets which results in the therapeutic effects in a variety of tumour types.\nHowever, despite recent progress and the availability of targeted kinase inhibitors for certain tumour types, resistance to drug and disease relapse develop in most tumours. Therefore there is a need to develop more effective kinase inhibitors with better benefit-risk profiles.\n\nThe study will be split into two “phases”; an Escalation Phase and Expansion Phase.\n\nDuring the escalation phase of this study, approximately 50 patients will receive different amounts of DCC-2618 once or twice daily to determine the highest safe dose and the optimal dose and regimen. Amounts of DCC 2618 given to patients will increase when it is determined that lower doses are safe.\n\nThe Escalation Phase will be followed by an Expansion Phase, where 150mg QD dose of DCC-2618 will be given to approximately 200 additional patients with specific tumour types. \nPatients in the UK will only be enrolled in the Expansion Phase of the study.\n\nPatients will be taking part in the study from about 30 investigational sites from United States, Canada and the European Union. \n\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0393
Date of REC Opinion
29 Nov 2017
REC opinion
Further Information Favourable Opinion