Neoplasms

Immune System Diseases

All Conditions

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Behaviors and Mental Disorders

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Rare Diseases

Mastocytosis

Leukemia

Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Renal Insufficiency

Glioma

Sarcoma

Lung Neoplasms

Gastrointestinal Stromal Tumors

Aggression

Mastocytosis, Systemic

Mast Cell Activation Disorders

Leukemia, Mast-Cell

Ichthyosis, X-Linked

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Soft Tissue Sarcoma

Germ Cells Tumors

Penile Cancer

Systemic Mastocytosis

Escalation Phase: DCC-2618 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours or once daily (QD) for repeated 28-day cycles. Participants may continue to receive study drug until discontinuation criteria are met. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 3 prior therapies. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 4 prior therapies. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received at least one prior therapy and no more than 2 prior therapies. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with systemic mastocytosis and other hematologic malignancies.\[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with malignant gliomas.\[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with other solid tumors. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with melanomas. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with soft tissue sarcomas.\[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with germ cell, penile cancer and non-small cell lung carcinoma (NSCLC). \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST and other solid tumors with renal impairment. \[Closed for Enrollment\]

150 mg DCC-2618 given once daily in repeated 28-day cycles for active patients from the Escalation and Extension Phases.

DCC-2618

Deciphera Pharmaceuticals, LLC

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.

A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

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

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.

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

Deciphera Pharmaceuticals LLC

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Acute Graft Versus Host Disease

Patients with advanced systemic mastocytosis who received treatment with avapritinib as part of the BLU-285-2101 and BLU-285-2202 studies

Patients with advanced systemic mastocytosis that received best available therapy

BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.

Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM

An External Control, Observational, Retrospective Study Assessing the Effect of Avapritinib Compared With Best Available Therapy for Patients With Advanced Systemic Mastocytosis

Overall Survival defined as time from initiation of systemic treatment to death from any cause

DOT, defined as the duration from initiation of line of systemic treatment to discontinuation of same line of treatment for any reason and;

TtNTL, defined as the time from initiation of the line of systemic treatment to the initiation of the next line of treatment

Change in serum tryptase concentration, defined as change in serum tryptase from baseline, for each line of therapy

AEs that result in treatment modification or discontinuation, hospitalization, or death according to evaluation of responsible physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies	NCT02571036	Gastrointestina... Advanced System... Advanced Cancer...	DCC-2618 DCC-2618	18 Years -	Deciphera Pharmaceuticals LLC
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies	NCT02571036	Gastrointestina... Advanced System... Advanced Cancer...	DCC-2618 DCC-2618	18 Years -	Deciphera Pharmaceuticals LLC
Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM	NCT04695431	Advanced System... Aggressive Syst... Systemic Mastoc... Mast Cell Leuke...		18 Years -	Blueprint Medicines Corporation

Spots Global Cancer Trial Database for advanced systemic mastocytosis