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Report for Clinical Trial NCT02571036

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Malignancies

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.

NCT02571036 Gastrointestinal Stromal Tumors Advanced Systemic Mastocytosis Advanced Cancers
MeSH:Gastrointestinal Stromal Tumors Mastocytosis Mastocytosis, Systemic
HPO:Gastrointestinal stroma tumor Mastocytosis

2 Interventions

Name: DCC-2618

Description: 50 mg formulated tablets
Type: Drug
Group Labels: 10

Expansion Cohort 1 Expansion Cohort 10 Expansion Cohort 2 Expansion Cohort 3 Expansion Cohort 4 Expansion Cohort 5 Expansion Cohort 6 Expansion Cohort 7 Expansion Cohort 8 Expansion Cohort 9

Name: DCC-2618

Description: 10 mg and 50 mg formulated tablets
Type: Drug
Group Labels: 1

Escalation


Primary Outcomes

Description: Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.

Measure: Safety/tolerability of oral DCC-2618: incidence of adverse events

Time: Approximately 24 months

Measure: Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose

Time: 18 months

Description: Objective response rate (ORR); Disease control rate (DCR)

Measure: Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases

Time: Approximately 24 months

Secondary Outcomes

Measure: Determine the PK profile of oral DCC-2618

Time: Predose and up to 24 hours postdose (Cycle = 28 Days)

Description: Objective response rate (ORR); Disease control rate (DCR)

Measure: Escalation Phase: Assess Antitumor Activity of DCC-2618 in patients with advanced malignancies

Time: Approximately 24 months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 D816V

Patients with de novo imatinib resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy. --- D816V ---


2 D842V

Patients with de novo imatinib resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy. --- D816V --- --- D842V ---



HPO Nodes


HPO: