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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Deciphera Pharmaceuticals LLC
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT02571036
First received: October 5, 2015
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Gastrointestinal Stromal Tumors
Aggressive Systemic Mastocytosis
Advanced Cancers
Drug: DCC-2618
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Deciphera Pharmaceuticals LLC:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 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.

  • Maximum dose that is tolerated by patients by the incidence and severity of treatment-related adverse events (Maximum Tolerated Dose) [ Time Frame: During Cycle 1 (28 day cycle) ]

Secondary Outcome Measures:
  • Time to maximum plasma concentration of DCC-2618 (Tmax) [ Time Frame: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
  • Maximum observed plasma concentration of DCC-2618 (Cmax) [ Time Frame: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
  • Plot of concentration of DCC-2618 in blood plasma against time [area under the concentration-time curve (AUC)] [ Time Frame: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
  • Period of time required for the concentration/amount of DCC-2618 in the body to be reduced by one-half [ Time Frame: Predose and up to 24 hours postdose (Cycle = 28 Days) ]
    Determination of half-life (t1/2)

  • Preliminary evidence of antitumor activity by objective response rate (complete response [CR] + partial response [PR]) [ Time Frame: At 12 weeks ]
  • Preliminary evidence of antitumor activity by disease control rate (complete response [CR] + partial response [PR] + stable disease [SD]) [ Time Frame: At 12 weeks ]
  • Plasma concentration levels with food interactions [ Time Frame: Day -7 ]

Estimated Enrollment: 50
Study Start Date: October 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escalation and Expansion

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

Expansion Phase: DCC-2618 tablets given at the dose and dosing regimen determined from the escalation phase with select advanced malignancies until discontinuation criteria are met.

Drug: DCC-2618
10 mg and 50 mg formulated tablets

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible to enroll in the study:

  1. Patients with solid tumor or hematologic malignancy must have a histologically confirmed, locally advanced malignancy refractory or intolerant to standard therapies and/or have no alternative effective therapy available, with the following exceptions:

    • GIST patients must have progressed at least on imatinib.
    • Systemic mastocytosis patients must have a confirmed diagnosis of aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) according to 2008 World Health Organization (WHO) criteria for SM.
  2. Solid tumor or hematologic malignancy require an archival biopsy sample as long as no cancer therapy was administered since the sample was collected; otherwise, a fresh biopsy is required.
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.
  4. The patient, or legally authorized representative, is capable of understanding and complying with the protocol and has signed the informed consent document.
  5. Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 14 days prior to the first dose of study drug:

    • Bone Marrow Function: ANC ≥1500/µL; hemoglobin ≥9 g/dL; platelet count ≥75,000/µL.
    • Hepatic Function: Total bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate transaminase (AST)/alanine transaminase (ALT), ≤3 × ULN (≤5 × ULN in the presence of hepatic metastases).
    • Renal Function: Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based either on urine collection or Cockcroft Gault estimation.
    • Coagulation Profile: Prothrombin time (PT) - international normalized ratio (INR)/partial thromboplastin time (PTT) ≤1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 × ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to enrollment.

SM patients with one or more inadequate organ function laboratory value may be eligible if both the Principal Investigator and Sponsor deem it to be disease related.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from the study:

  1. Patients with leukemias, with the exception of MCL.
  2. Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to the administration of study drug. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days prior to the first administration of study drug.
  3. Unresolved toxicity NCI CTCAE Version 4.03 (i.e., >Grade 1 or baseline) from previous anticancer therapy, excluding alopecia.
  4. The patient has known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate.
  5. New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition.
  6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks), pulmonary embolism, or hemoptysis within 6 months before start of study drug.
  7. Venous thrombotic events (e.g. deep vein thrombosis) within the 3 months before start of study drug.
  8. Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF >450 ms in males or >470 ms in females or history of long QTc syndrome.
  9. Left ventricular ejection fraction <50% or below the lower limit of normal (whichever is higher).
  10. Concurrent treatment with proton-pump inhibitor.
  11. Major surgery within 4 weeks of the first dose of study drug.
  12. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
  13. Malabsorption syndrome or other illness that could affect oral absorption.
  14. Known human immunodeficiency virus, active hepatitis B, or active hepatitis C infection.
  15. If female, the patient is pregnant or lactating.
  16. Known allergy or hypersensitivity to any component of the investigational drug product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02571036

Contacts
Contact: Jama Pitman jpitman@deciphera.com

Locations
United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States
United States, Massachusetts
Dana Farber Recruiting
Boston, Massachusetts, United States
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States
Canada
Princess Margaret Recruiting
Toronto, Canada
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Investigators
Study Director: Deciphera Pharmaceuticals, LLC Deciphera Pharmaceuticals LLC
  More Information

Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02571036     History of Changes
Other Study ID Numbers: DCC-2618-01-001
Study First Received: October 5, 2015
Last Updated: February 9, 2016

Keywords provided by Deciphera Pharmaceuticals LLC:
Gastrointestinal stromal tumors (GIST)
systemic mastocytosis (SM)
PDGFR-alpha
KIT
mast cell leukemia (MCL)
mast cell disease (MCD)
DCC-2618
melanoma
aggressive systemic mastocytosis (ASM)

Additional relevant MeSH terms:
Aggression
Gastrointestinal Stromal Tumors
Mastocytosis, Systemic
Mastocytosis
Behavioral Symptoms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 27, 2017