EUCTR2018-004004-19-ES进行中（未招募）1 期
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib versus Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations: The PROOF Trial - The PROOF Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Have histologically or cytologically confirmed non-resectable, recurrent, or metastatic cholangiocarcinoma. Subjects with gallbladder cancer or ampulla of Vater carcinoma are not eligible.
- •2. Have written documentation of local or central laboratory determination of FGFR2 gene fusions/translocations. Note: Central confirmation is not required prior to enrollment in study.
- •3. Have a representative tumor sample available for central FGFR2 fusion/translocation molecular testing. An archival tumor sample and associated pathology report may be submitted. However, if not available, a newly obtained tumor biopsy may be submitted instead.Note: If available FGFR2 fusion/translocation written documentation is from the central laboratory being used in the study, a tumor sample does not need to be submitted for central FGFR2 fusion/translocation molecular testing.
- •4. Have full recovery from the following permitted prior treatments (as applicable) such that the subject is reasonably expected to tolerate study treatment (gemcitabine/cisplatin or infigratinib) according to the investigator’s assessment:
- •a. A non-curative operation (ie., R2 resection [with macroscopic residual disease] or palliative bypass surgery only)
- •b. Curative surgery with evidence of non-resectable disease relapse requiring systemic chemotherapy
- •c. Adjuvant radiotherapy (with or without radio-sensitizing low-dose chemotherapy) for localized disease provided there has been clear evidence of disease progression before inclusion in this study
- •d. Adjuvant chemotherapy, provided the treatment was completed > 6 months before trial entry
- •e. Photodynamic treatment provided there is clear evidence of disease progression at the local site or at a new metastatic site.
- •5. Are = 18 years of age of either gender.
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status = 1.
- •7. Have a life expectancy > 3 months.
- •8. Are able to read and/or understand the details of the study and provide written evidence of informed consent as approved by Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •9. Have recovered from AEs of previous systemic anti-cancer therapies to baseline or Grade 1, except for alopecia.
- •10. Are able to swallow and retain oral medication.
- •11. Are willing and able to comply with scheduled visits, treatment plan and laboratory tests.
- •12. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test within 7 days of the first dose of study drug. A woman is not of childbearing potential if she has undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug) or if she is postmenopausal and has had no menstrual bleeding of any kind including menstrual period, irregular bleeding, spotting, etc., for at least 12 months, with an appropriate clinical profile, and there is no other cause of amenorrhea (eg., hormonal therapy, prior chemotherapy).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
排除标准
- •1. Have received treatment with any systemic anti-cancer therapy for unresectable, recurrent, or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months prior to first dose of study drug.
- •2. Have history of a liver transplant.
- •3. Have received prior or current treatment with a MEK or selective FGFR inhibitor.
- •4. Have neurological symptoms related to underlying disease requiring increasing doses of corticosteroids. Note: Steroid use for management of central nervous system tumors is allowed but must be at a stable dose for at least 2 weeks preceding study entry.
- •5. Have a history of another primary malignancy within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
- •6. Have any other medical condition that would, in the investigator’s judgment, prevent the subject’s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- •7. Have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
- •8. Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.
- •9. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (eg., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- •10. Have current evidence of endocrine alterations of calcium/phosphate homeostasis, eg., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
- •11. Are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone.
- •12. Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug.
- •13. Have used medications known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug.
- •14. Have used amiodarone within 90 days prior to first dose of study drug.
- •15. Are currently using therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants or using direct thrombin inhibitors (e.g., argatroban) or Factor Xa inhibitors (e.g., rivaroxaban) that are primarily metabolized by CYP3
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