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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

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

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:
Gastrointestinal stroma tumor
Genes 25
PDGFRA CD19 SDHB KIT CD81 SDHC PRKCD SDHB TNFRSF13B TNFRSF13C MS4A1 NFKB1 KIT NFKB2 SDHA SDHC TNFSF12 SDHC CR2 ICOS TNFSF12 SDHB SDHB SDHD KIT
Mastocytosis
Genes 8
KIT ASXL1 KIT TET2 KIT KIT KIT SRSF2