[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

785-830-2100

Email address

clinicaltrials@deciphera.com

Condition

Gastrointestinal Stromal Tumors

Treatment type

Interventional

Investigational product

DCC-2618

Phase

Phase 3

Sponsor

Deciphera Pharmaceuticals LLC

ClinicalTrials.gov identifier

NCT03673501

Study number

DCC-2618-03-002

Understanding clinical trials

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About the study

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 426 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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. ECOG) PS of ≤ 2 at screening. 6. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-
  2. 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 slice thickness in the long
  3. 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
  4. 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 the patient has signed the informed consent document. Signed informed consent form (
  5. ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational
  6. studies) is permitted.
Exclusion criteria
  1. LVEF) < 50% at screening. 6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic
  2. attacks) or hemoptysis within 6 months before the first dose of study drug. 7. Venous thrombotic events (e.g. deep vein
  3. thrombosis) or pulmonary arterial events (e.g. pulmonary
  4. 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 (
  5. 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
  6. longer) prior to the first dose of study drug. 10. Major surgeries (e.g. abdominal
  7. 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 (
  8. IV) alimentation 16. Any active bleeding excluding hemorrhoidal or gum bleeding.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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