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

Phase 1

Completed

• Conditions: Advanced Systemic Mastocytosis; Gastrointestinal Stromal Tumors; Advanced Cancers
• Interventions: Drug: DCC-2618

• Registration Number: NCT02571036
• Lead Sponsor: Deciphera Pharmaceuticals, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Study Start: 2015-11
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expansion Cohort 1	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 3 prior therapies. \[Closed for Enrollment\]
Extension Cohort	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles for active patients from the Escalation and Extension Phases.
Escalation	DCC-2618	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. \[Closed for Enrollment\]
Expansion Cohort 6	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with other solid tumors. \[Closed for Enrollment\]
Expansion Cohort 9	DCC-2618	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). \[Closed for Enrollment\]
Expansion Cohort 5	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with malignant gliomas.\[Closed for Enrollment\]
Expansion Cohort 10	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST and other solid tumors with renal impairment. \[Closed for Enrollment\]
Expansion Cohort 2	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 4 prior therapies. \[Closed for Enrollment\]
Expansion Cohort 3	DCC-2618	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. \[Closed for Enrollment\]
Expansion Cohort 4	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with systemic mastocytosis and other hematologic malignancies.\[Closed for Enrollment\]
Expansion Cohort 7	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with melanomas. \[Closed for Enrollment\]
Expansion Cohort 8	DCC-2618	150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with soft tissue sarcomas.\[Closed for Enrollment\]

Primary Outcome Measures

Name	Time	Method
Safety/tolerability of oral DCC-2618: incidence of adverse events	Approximately 24 months	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.
Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose	18 months
Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases	Approximately 24 months	Objective response rate (ORR); Disease control rate (DCR)

Secondary Outcome Measures

Name	Time	Method
Escalation Phase: Assess Antitumor Activity of DCC-2618 in patients with advanced malignancies	Approximately 24 months	Objective response rate (ORR); Disease control rate (DCR)
Determine the PK profile of oral DCC-2618	Predose and up to 24 hours postdose (Cycle = 28 Days)

Trial Locations

Locations (26)

Honor Health (GIST, mastocytosis, other solid tumors); 🇺🇸 Scottsdale, Arizona, United States

UCLA (glial malignancies only); 🇺🇸 Los Angeles, California, United States

Stanford University Hematology Clinic (mastocytosis); 🇺🇸 Palo Alto, California, United States

UCLA Hematology Center (mastocytosis); 🇺🇸 Los Angeles, California, United States

Stanford University Comprehensive Cancer Center (GIST); 🇺🇸 Palo Alto, California, United States

UCSF (glial malignancies only); 🇺🇸 San Francisco, California, United States

Dana Farber Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 Jacksonville, Florida, United States

University of Miami (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 Miami, Florida, United States

OHSU (GIST & mastocytosis only); 🇺🇸 Portland, Oregon, United States

Colombia University Medical Center (mastocytosis); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 New York, New York, United States

Huntsman Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 Salt Lake City, Utah, United States

Fox Chase Cancer Center (GIST only); 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Commonwealth University School of Medicine (mastocytosis); 🇺🇸 Richmond, Virginia, United States

MD Anderson Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors); 🇺🇸 Houston, Texas, United States

Princess Margaret Cancer Centre (GIST, other solid tumors); 🇨🇦 Toronto, Canada

HELIOS Klinikum Berlin-Buch (GIST, and other solid tumors); 🇩🇪 Berlin, Germany

Uniklinik RWTH Aachen (mastocytosis, GIST, and other solid tumors); 🇩🇪 Aachen, Germany

Essen University Hospital (mastocytosis, GIST, and other solid tumors); 🇩🇪 Essen, Germany

Leiden University Medical Center (GIST and other solid tumors); 🇳🇱 Leiden, Netherlands

University Hospital of Verona (mastocytosis); 🇮🇹 Verona, Italy

Freiburg University Hospital (mastocytosis, and other solid tumors); 🇩🇪 Freiburg, Germany

University Medical Centre Mannheim (mastocytosis); 🇩🇪 Mannheim, Germany

Royal Marsden Hospital (GIST, glial malignancies, other solid tumors); 🇬🇧 London, United Kingdom

Guy's Hospital (mastocytosis only); 🇬🇧 London, United Kingdom