CTRI/2021/11/038092招募中2 期
A Phase II Open-Label Trial Evaluating the Efficacy and Safety of Once Daily Oral ODM-203 in Patients with Unresectable Transitional Cell Urothelial Carcinoma with FGFR3 Mutation - TEJAS-1
Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males and females >= 18 years of age
- •2.Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- •3.Patients with histologically confirmed Unresectable Urothelial Transitional Cell Carcinoma
- •4.Patient should have received at least 1 line and a maximum of 2 prior lines of systemic therapy (Patients who have received chemotherapy in an adjuvant or neoadjuvant setting are also eligible as long as the tumor has relapsed during or within 12 months of having completed the adjuvant / neoadjuvant therapy)
- •5.Patient consents for pre-screening for FGFR3 mutation testing on available archival or fresh tissue sample.
- •6.Positive for FGFR3 mutation (fusion and/or non-fusion mutation)
- •7.Patient consents for germline testing for UGT1A1 polymorphism.
- •8.Patients with homozygous wild type (wt/wt) genotype or heterozygous wild type allele
- •9.Evidence of measurable disease per RECIST, v1.1.
- •10.Acceptable bone marrow function, organ function and serum electrolytes at screening as described below:
- •a.Absolute neutrophil count (ANC) >= 1.5 x 109/L (1500 per mm3) (without WBC growth factor support)
- •b.Platelet count >= 90 x 109/L (90,000 per mm3) without platelet transfusion support
- •c.Hemoglobin (Hb) >= 9.0 g/dL (Blood could be transfused during screening period, to bring Hb to this level)
- •d.Total Bilirubin <= 1.2 x ULN
- •e.AST (SGOT) <= 1.5 x ULN [<= 3 Ã? ULN if known liver metastases or the tumor invades the liver]
- •f.ALT (SGPT) <= 1.5 x ULN [<= 3 Ã? ULN if known liver metastases or the tumor invades the liver]
- •g.Serum creatinine <= 2 mg/dL or a measured creatinine clearance >= 40 mL/min according to Cockcroft-Gault formula.
- •h.Serum Phosphate, Calcium, Potassium and Sodium in normal range or <= Grade 1 increase / decrease
- •11.Ability to swallow and retain oral medications.
- •12.Negative serum pregnancy test in women of childbearing potential (WOCBP)
- •13.Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) for contraception, as detailed in section 7.18 of the protocol, for the duration of the study, i.e., through 28-day safety follow up visit.
- •14.Willing and able to provide written informed consent and comply with the requirements of the trial
排除标准
- •1. Patients without FGFR3 mutation
- •2. Patients without any wild type allele genotypes for UGT1A1
- •3. Systemic anti-cancer therapy, such as chemotherapy, or immunotherapy received within the past 28 days or 5 half-lives of Cycle 1 Day 1, whichever is longer.
- •4. Radiotherapy within the previous 14 days of Cycle 1 day 1
- •5. Patients who have received an approved or investigational FGFR inhibitor in the past.
- •6. Use of any investigational agent within 28 days or 5 half-lives prior to Cycle 1 day 1.
- •7. Presence of an acute or chronic toxicity resulting from prior systemic therapy, such as chemotherapy
- •8. CNS metastases
- •9. Major surgery less than 21 days from the start of treatment
- •10. Current active infection requiring systemic therapy.
- •11. Known to be positive for HIV or AIDS or hepatitis B or hepatitis C or Identified during Screening
- •12. >= Grade 2 retinopathy and/or >= Grade 2 keratitis at screening ophthalmic examination
- •13. Any severe, acute, or chronic medical, psychiatric or social condition or laboratory abnormality
- •14. Previous or concomitant additional malignancy within the last 5 years prior to study entry
- •15. Pregnant or lactating women
- •16. CHF, MI, Angina, Pulmonary embolism within 3 months prior to initiation of study drug.
- •17. Left Ventricular Ejection Fraction (LVEF) < 50 percent at screening.
- •18. Left Ventricular Ejection Fraction (LVEF) < 50 percent at screening.
- •19. Gastrointestinal disease or disorders that may interfere with the tolerance or absorption of orally- administered drugs.
- •20. Previous or concomitant additional malignancy within the last 5 years prior to study entry
研究者
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