EUCTR2011-004072-10-GB进行中（未招募）1 期
FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin - FIESTA
niversity of Leeds0 个研究点目标入组 28 人开始时间: 2012年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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
- •Provision of written, informed consent, signed and dated, prior to any trial-specific procedures, sampling or analyses
- •Age =25 years.
- •Histologically-confirmed locally advanced/metastatic non-haematological malignancy (a diagnosis based upon cytology is not acceptable).
- •Dose escalation cohort:
- •- Any locally-advanced and/or metastatic solid cancer for which gemcitabine and cisplatin is either an accepted standard treatment or for which there is no remaining standard treatment, but gemcitabine and cisplatin with AZD4547 is a reasonable option in the context of a clinical trial. Any number of previous lines of therapy are permitted
- •- Locally advanced and/or metastatic transitional cell carcinoma of the bladder (or other urinary tract sites), as in the randomised expansion cohort, may be included in the dose escalation cohort
- •Randomised Expansion cohort:
- •- Locally advanced and/or metastatic transitional cell carcinoma (pure or mixed histology) of (upper or lower) urinary tract, including bladder cancer. No prior systemic therapy for locally advanced or metastatic disease; patients who have received prior neoadjuvant or adjuvant chemotherapy for potentially-curable urothelial cancer (up to 4 cycles), completed at least 6 months prior to first documented disease progression, will be eligible.
- •Radiologically measurable disease (randomised expansion cohort only)
- •T4b Nany Many, Tany N2-3 Many or Tany Nany M1 TCC of the urinary tract (as above), not amenable to curative treatment with surgery or radiotherapy.
- •Minimum life expectancy of 3 months
- •WHO Performance Status 0-1
- •Adequate renal function (GFR =60ml/min, measured by isotopic means, uncorrected for surface area)
- •Adequate bone marrow function (absolute neutrophil count =1.5 x 10^9/L and platelets =100 x 10^9/L)
- •Adequate liver function i.e. plasma bilirubin =1.5 x ULN, and ALT and ALP =2.5 x ULN (ALP =5 x ULN in case of liver metastases)
- •Prothrombin time (PT) =1. 5 x ULN or International Normalized Ratio (INR) =1. 5
- •Serum total calcium and/or phosphate = ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Being considered for subsequent radical treatment with the possibility of cure
- •Prior treatments with any of the following, prior to first dose of trial treatment:
- •a.AZD4547 or any other agent known to inhibit FGFRs
- •b.Any Investigational Medicinal Products within 30 days
- •c.Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks
- •d.Concomitant medications as documented in the protocol and unable to meet any washout periods as required.
- •e. Major surgery within 4 weeks
- •f.Radiotherapy
- •i.with a wide field of radiation or involving >30% of total bone marrow volume, within 4 weeks
- •ii.with a limited field of radiation, for palliation, within 2 week
- •Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia) at the time of registration
- •Any of the following pre-existing conditions:
- •a.Other malignant disease
- •i.(Randomised expansion cohort only) Recent or concurrent active malignancy arising from a primary site other than the urinary tract; participants with a history of a separate, treated malignancy, diagnosed 5 or more years previously, can be regarded as cured of their previous tumour, for the purposes of this trial, and may be entered. Current active non-melanoma skin cancer, cervical carcinoma in situ or incidental, localised prostate cancer are also permissible.
- •b.Previously-identified central nervous system (CNS) metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of trial treatment.
- •c.Infections
- •d.Gastro-intestinal: any condition which might preclude adequate absorption of AZD4547 (e.g. previous small bowel resection)
- •e.Cardiac: unstable cardiac conditions and risk factors for QTc prolongation.
- •f.Ophthalmic conditions
- •History of allergic reactions to any of the drugs used in this trial
- •Unsuitable to receive cisplatin or gemcitabine
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses
- •Women who are pregnant or breast feeding - women of child-bearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial treatment
- •Men or women who are not prepared to practise methods of contraception of proven efficacy
研究者
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