A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies (NCT02571036) | Clinical Trial Compass
CompletedPhase 1
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
United States282 participantsStarted 2015-11
Plain-language summary
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients ≥18 years of age.
✓. Patients must have histologically confirmed solid tumors or hematologic malignancies. Eligible patients include the following:
✓. GIST patients must have a KIT and PDGFRA mutation and must have progressed on or had an intolerability to at least 1 line of systemic anticancer therapy.
✓. SM patients must have a confirmed diagnosis of advanced SM according to 2016 World Health Organization (WHO) criteria for SM and must have documented KIT mutant disease. Patients with imatinib-sensitive KIT mutations must have progressed on or were intolerant to a tyrosine kinase inhibitor. Patients with advanced SM must present with at least 1 eligible C-Finding (organ damage) per 2013 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) \& European Competence Network on Mastocytosis consensus response criteria; please see below for MCL exception.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2.
✓. Adequate organ function and bone marrow function.
Exclusion criteria
✕. GIST patients with wild type or unknown KIT or PDGFRA status.
✕. Patients with SM or other hematologic malignancies will be excluded if the following apply:
✕. SM patients with neutropenia accompanied by fever or infection, or thrombocytopenia associated with clinically significant bleeding.
✕. SM-AHN patients diagnosed with:
What they're measuring
1
Safety/tolerability of oral DCC-2618: incidence of adverse events
Timeframe: Approximately 24 months
2
Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose
Timeframe: 18 months
3
Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases
✕. Prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of DCC-2618. Patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol.
✕. New York Heart Association class III and IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
✕. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before start of study drug.
✕. Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within the 3 months before start of study drug. Patients with venous thrombotic events ≥3 months before start of study drug on stable anticoagulation therapy are eligible.