NL-OMON50251已完成3 期
A Phase 3, INterVentional, Double-Blind, Placebo Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapies - INVICTUS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients >=18 years of age at the time of informed consent
- •2. Histologic diagnosis of GIST
- •3.Patients must have progressed on imatinib, sunitinib, and regorafenib or have
- •documented intolerance to any of these treatments despite dose modifications.
- •4. ECOG PS of 0 to 2 at screening.
- •5. Able to provide an archival tumor tissue sample if no anticancer therapy was
- •administered since the sample was collected; otherwise, a fresh tumor tissue
- •sample is required prior to the first dose of study drug.
- •6. Female patients of childbearing potential must have a negative serum
- •beta-human chorionic gonadotrophin (β-hCG) pregnancy test at screening and a
- •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 Section 6.11.10 of the study protocol.
- •8. The patient is capable of understanding and complying with the protocol and
- •has signed the informed consent document. A signed informed consent form must
- •be obtained before any study-specific procedures are performed.
- •9. At least 1 measurable lesion according to modified RECIST 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
- •10. Adequate organ function and bone marrow reserve as indicated by
- •the following laboratory assessments performed at screening.
- •Absolute neutrophil count >=1000/µL
- •Hemoglobin >=8 g/dL
- •Platelet count >=75,000/µL
- •Total bilirubin <=1.5 x the upper limit of normal (ULN)
- •Aspartate transaminase and alanine transaminase <=3 x ULN (<=5x ULN in the
- •presence of hepatic metastases)
- •Serum creatinine <=1.5 x ULN or creatinine clearance >=50 mL/min based on
- •either urine collection or Cockcroft Gault estimation.
- •Prothrombin time (PT), international normalized ratio (INR), and partial
- •thromboplastin time <=1.5 x 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 x 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 randomization.
- •11. Resolution of all toxicities from prior therapy to <=Grade 1 (or baseline)
- •within 1 week prior to the first dose of study drug (excluding alopecia and
- •<=Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase
- •laboratory abnormalities).
排除标准
- •1. Treatment with anticancer therapy, including investigational therapy, or
- •investigational procedures within 14 days or 5 x the half life (whichever is
- •longer) prior to the first dose of study drug. For prior biological therapies,
- •eg, monoclonal antibodies with a half life longer than 3 days, the interval
- •must be at least 28 days prior to the first dose of study drug.
- •2. Prior treatment with DCC-2618.
- •3. Prior or concurrent malignancy whose natural history or treatment have
- •the potential to interfere with the safety or efficacy assessment of DCC-2618.
- •Patients receiving adjuvant cancer treatment are not eligible if those
- •medications are potentially active against GIST or excluded per protocol (refer
- •to Section 5.12.3 of the protocol).
- •4. Patient has known active central nervous system metastases.
- •5. New York Heart Association class II - IV heart disease, active ischemia or
- •any other uncontrolled cardiac condition such as angina pectoris, clinically
- •significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or
- •congestive heart failure.
- •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 (eg, deep vein thrombosis) or pulmonary arterial
- •events (eg, pulmonary embolism) within 3 months before the first dose of study
- •drug. Patients with venous thrombotic events >=3 months before the first dose of
- •study drug on stable anticoagulation therapy are eligible.
- •8. 12 lead electrocardiogram (ECG) demonstrating QT interval corrected by
- •Fridericia*s formula >450 ms in males or >470 ms in females at screening or
- •history of long QT interval corrected syndrome.
- •9. Left ventricular ejection fraction (LVEF) <50% at screening.
- •10. Use of proton-pump inhibitors within 4 days prior to the first dose of
- •study drug. Other medications that increase gastric pH, ie, histamine H2
- •receptor antagonists and antacids may be taken provided they are not
- •administered within 2 hours before or after administration of study drug.
- •11. Use of strong or moderate inhibitors and inducers of cytochrome P450 (CYP)
- •3A4, including certain herbal medications (eg, St. John*s Wort) and consumption
- •of grapefruit or grapefruit juice within 14 days or 5 x the half life
- •(whichever is longer) prior to the first dose of study drug. Please refer to
- •the Indiana University Department of Medicine website
- •(http://medicine.iupui.edu/clinpharm/ddis/main-table/) for guidance on
- •medications that inhibit CYP3A4 enzymes.
- •12 Use of known substrates or inhibitors of breast cancer resistance protein
- •(BCRP) transporters within 14 days or 5 x the half life (whichever is longer)
- •prior to the first dose of study drug. Please refer to the US Food and Drug
- •Administration*s (FDA) website
- •(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/
- •DrugInteractionsLabeling/ucm093664.htm) for inhibitors and substrates.
- •13. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose
- •of study drug. Following major surgeries, >4 weeks prior to the first dose of
- •study drug, all surgical wounds must be healed and free of infection or
- •dehiscence.
- •14. Any other clinically significant comorbidities, such as uncontrolled
- •pulmonary disease, active infect
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