Phase 1 Open-Label Study of DCC-3014
Research type
Research Study
Full title
A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors
IRAS ID
272396
Contact name
Beatrice Seddon
Contact email
Sponsor organisation
Deciphera Pharmaceuticals, LLC
Eudract number
2019-001856-21
Clinicaltrials.gov Identifier
131218, IND
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
A new compound named DCC 3014 is being developed by Deciphera Pharmaceuticals, LLC, as an oral study medicine for the treatment of advanced tumours.
About 50 people, 18 years of age and older, at about 10 sites will take part in Part 1 of the study, called the “escalation part”. During Part 1, participants will receive different doses of study medicine to determine the highest safe dose/ optimal dose regimen. The study doctor and study staff will monitor if certain side effects occur. As long as the side effects are tolerable, the dose will be increased for the next group of participants until a reasonable dose level and schedule (i.e., one that causes no side effects or only tolerable side effects) is found. . Additionally, lower or intermediate dose level(s) and/or alternate dose schedule(s) may be explored to determine an RP2D for DTGCT patients
When the highest dose level (and ideal dose schedule) of study medicine that participants can tolerate is found, 52 additional participants (12 patients with malignant solid in cohort A and tumor and 40 patients with DTGCT in cohort B) may receive that dose in Part 2 of the study, called the “expansion part”. Additional study sites (about 15 more) will also join the study for expansion.
Th UK site will be taking part only in the expansion with DTGCT patients (cohort B). Please note, the UK will not participate in solid tumour portion of the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0350
Date of REC Opinion
12 Jun 2020
REC opinion
Further Information Favourable Opinion