NL-OMON53522撤回不适用
Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions - Ph1 Study of Erdafitinib Intravesical Delivery System for Bladder Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 1. >=18 years (or the legal age of consent in the jurisdiction in which the
- •study is taking place) at the time of informed consent. Type of Participant and
- •Disease Characteristics 2. Recurrent, non-muscle-invasive or muscle-invasive
- •urothelial carcinoma of the bladder. a) Mixed histology tumors are allowed if
- •urothelial differentiation is predominant (ie, <20% variant histology).
- •However, the presence of micropapillary, signet ring cell, plasmacytoid,
- •neuroendocrine, or sarcomatoid features are exclusionary. b)High-risk papillary
- •disease (Cohorts 1 [Parts 1 and 2] and 2 [Part 2 only]), defined as
- •histologically confirmed high-grade Ta/T1 lesion. Concurrent CIS is not
- •allowed. All visible tumor must be completely resected prior to the start of
- •study treatment and documented on screening cystoscopy c) Intermediate-risk
- •papillary disease (Cohort 3, Parts 1 and 2) defined as all previous tumors
- •being low grade, Ta or T1, and no previous CIS. Cystoscopic documentation of
- •recurrence is sufficient. Negative urine cytology for high grade urothelial
- •carcinoma is required. Visible disease must be present at the time of first
- •TAR-210 insertion. d) Muscle-invasive disease (Cohort 4, Part 2 only) cT2-T3a,
- •N0. Participants must have a total tumor size <=3 cm after TURBT at cystoscopic
- •assessment within 8 weeks prior to the start of study treatment or must have a
- •second debulking TURBT to reduce the tumor(s) to <=3 cm in order to be eligible.
- •3. Activating tumor FGFR mutation or fusion, as determined by local* or central
- •testing, approved by the sponsor prior to the start of study treatment: * Local
- •tissue-based results (if already existing) from next-generation sequencing
- •(NGS) or polymerase chain reaction (PCR) tests performed in CLIA-certified or
- •equivalent laboratories, or results from commercially available PCR or NGS
- •tests. 4. Cohorts 1 and 2: BCG experienced, or participants with no BCG
- •experience because BCG was not available as a treatment option in the
- •participant*s location within the previous 2 years and is currently
- •unavailable. Participants who received an abbreviated course of BCG due to
- •toxicity are still eligible. BCG experienced is defined as: - Recurrent
- •high-grade Ta/T1 disease within 18 months of completion of prior BCG therapy -
- •Prior BCG (minimumtreatment requirements ): At least 5 of 6 full doses of an
- •initial induction course. Full dose BCG defined as 1 full vial containing a
- •minimum of 1 X 108 colony forming units. Note: Cohort 3 has no predefined prior
- •BCG or intravesical chemotherapy requirement. 5. Cohort 1 only: Refuses or is
- •not eligible for radical cystectomy 6. Cohorts 2 and 4 : willing and eligible
- •for radical cystectomy 7. Cohort 4: Refuses (and understands the risks and
- •benefits of doing so) cisplatin-based combination chemotherapy or is deemed
- •ineligible for cisplatin-based chemotherapy by meeting at least one of the
- •following criteria: - Creatinine clearance (CrCl)<60 mL/min - NCI-CTCAE v.5.0
- •Grade >=2 audiometric hearing loss - NCI-CTCAE v.5.0 Grade >=2 peripheral
- •neuropathy 8. Eastern Cooperative Oncology Group (ECOG) performance status
- •score of <=2 (Cohorts 1 and 3)or <=1 (Cohorts 2 and 4)(see Section 10.9 for ECOG
- •scoring) 9. Adequate bone marrow, liver, and renal function: a. Bone marrow
- •function (without the support of growth factor
排除标准
- •Medical Conditions 1. Concurrent extra-vesical (ie, urethra, ureter, renal
- •pelvis) transitional cell carcinoma of the urothelium. 2. Prior treatment with
- •an FGFR inhibitor. 3. Known hypersensitivity to any study component including:
- •- Erdafitinib (or other drug excipients) or chemically related drugs, - TAR-210
- •device constituent materials, - UPC materials. Refer to the TAR-210 IB for
- •complete information on excipients, device constituent materials, and UPC
- •materials 4. Received pelvic radiotherapy <=6 months prior to the planned start
- •of study treatment. If received pelvic radiotherapy >6 months prior to the
- •start of study treatment, there must be no cystoscopic evidence of radiation
- •cystitis. 5. Presence of any bladder or urethral anatomic feature that in the
- •opinion of the investigator may prevent the safe placement, indwelling use, or
- •removal of TAR-210. 6. Indwelling urinary catheter. Intermittent
- •catheterization is acceptable. 7. Cystoscopic evidence of bladder perforation
- •unless such perforation has resolved prior to dosing. 8. Bladder post-void
- •residual volume (PVR) >350 mL after second voided urine. 9. History of
- •clinically significant polyuria with recorded 24-hour urine volumes >4,000 mL.
- •10 Subjects with active bladder stones or history of bladder stones <6 months
- •prior to the start of study treatment. 11. Active malignancies (ie, progressing
- •or requiring treatment change in the last 24 months) other than the disease
- •being treated under study. Potential allowed exceptions include the following
- •(others maybe allowed with sponsor approval) a. skin cancer (non-melanoma or
- •melanoma)that is considered completely cured. b. non-invasive cervical cancer
- •that is considered completely cured. c. adequately treated lobular carcino main
- •situ(LCIS)and ductal CIS d. history of localized breastcancer and receiving
- •antihormonal agents e. history of localized prostate cancer (N0M0) and
- •receiving androgen deprivation therapy f. Localized prostate cancer (N0M0) -
- •with a Gleason score of 6, treated within the last 24 months or untreated and
- •under surveillance, - with a Gleason score of3+4 that has been treated more
- •than 6 months prior to full study Screening and considered to have a very low
- •risk of recurrence, - or history of localized prostate cancer and receiving
- •androgen deprivation therapy and considered to have a very low risk of
- •recurrence. 12. Current central serous retinopathy or retinal pigment
- •epithelial detachment of any grade. 13. History of uncontrolled cardiovascular
- •disease including: - Any of the following within 3 months prior to the start of
- •study treatment: unstable angina, myocardial infarction, ventricular
- •arrhythmias or clinically significant atrial arrythmias (eg, atrial
- •fibrillation with uncontrolled rate), cardiac arrest, or known congestive New
- •York Heart Association Class III-IV heart failure (Appendix 10),
- •cerebrovascular accident, or transient ischemic attack. - Pulmonary embolism or
- •other venous thromboembolism within 1 month prior to the planned start of study
- •treatment. 14. Active or chronic hepatitis B or C infection according to the
- •following criteria: - Seropositive for hepatitis B: defined by a positive test
- •for hepatitis B surface antigen [HBsAg]. Participants with resolved infection
- •(ie, participants who are HbsAg negative with antibod
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