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Trial record 2 of 3 for:    DCC-2618

A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)

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ClinicalTrials.gov Identifier: NCT03673501
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Brief Summary:
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: DCC-2618 Drug: Sunitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: DCC-2618
150 mg QD DCC-2618
Drug: DCC-2618
Oral KIT/PDGFRA kinase inhibitor

Active Comparator: sunitinib
50 mg QD sunitinib
Drug: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Other Name: Sutent




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 30 months ]
    PFS Based on independent radiologic review using modified RECIST


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 30 months ]
    Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review

  2. Overall Survival (OS) [ Time Frame: 30 months ]
    Measure of overall survival



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients ≥ 18 years of age at the time of informed consent.
  2. Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
  3. Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
  4. Patients must have progressed on imatinib or have documented intolerance to imatinib.
  5. Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
  6. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
  7. Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
  8. Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.
  9. Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
  10. Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
  11. The patient is capable of understanding and complying with the protocol and has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed.

Exclusion Criteria:

  1. Treatment with any other line of therapy in addition to imatinib for advanced GIST.
  2. Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
  3. Patient has known active central nervous system metastases.
  4. New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
  5. Left ventricular ejection fraction (LVEF) < 50% at screening.
  6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
  7. Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
  8. 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QTc syndrome
  9. Use of known substrates or inhibitors of BCRP transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
  10. Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
  11. Any other clinically significant comorbidities.
  12. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
  13. If female, the patient is pregnant or lactating.
  14. Known allergy or hypersensitivity to any component of the study drug.
  15. Gastrointestinal abnormalities including but not limited to:

    • inability to take oral medication
    • malabsorption syndromes
    • requirement for intravenous (IV) alimentation
  16. Any active bleeding excluding hemorrhoidal or gum bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673501


Contacts
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Contact: Clinical Team 785-830-2100 clinicaltrials@deciphera.com

Locations
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United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80220
Contact: Allen Cohn         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Attia    904-953-7292      
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Jonathan Trent         
Miami Cancer Institute at Baptist Health, Inc. Recruiting
Miami, Florida, United States, 33176
Contact: Antonio Ucar         
United States, Georgia
Georgia Cancer Specialists Recruiting
Sandy Springs, Georgia, United States, 30342
Contact: Bordoni         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Siontis         
United States, Ohio
University of Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact: Nemunaitis         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: vonMehren         
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Paulson         
United States, Virginia
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Reilley         
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC

Additional Information:
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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03673501     History of Changes
Other Study ID Numbers: DCC-2618-03-002
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Sunitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors