NL-OMON55032已完成3 期
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302) - QED_PROOF 302
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 64（—）
入选标准
- •1. Are >=18 years of age (>=20 years of age in Taiwan) of either sex.
- •2. Have signed informed consent.
- •3. Are randomized within 120 days following nephroureterectomy, distal
- •ureterectomy, or cystectomy. Note: at the time of definitive surgery,
- •lymph node dissection (LND) should be performed in cases of suspected
- •lymph node invasion based on preoperative imaging or intraoperative
- •findings. In other cases, LND is to be performed in accordance with
- •surgeon preferences/local standard practices. Additional details on
- •recommended standards for LND are provided in the protocol.
- •4. Have histologically or cytologically confirmed, invasive urothelial
- •carcinoma with susceptible FGFR3 alterations. Variant histology is
- •allowed provided urothelial carcinoma is predominant (>50%).
- •Neuroendocrine (including small and large cell), sarcomatoid, and
- •plasmacytoid variants are excluded (any component):
- •a. Regarding samples and documentation of FGFR3 alterations:
- •i. FGFR3 mutation is confirmed if: FGFR3 gene is mutated in Exon 7
- •(R248C, S249C), Exon 10 (G370C, A391E, Y373C), or Exon 15 (K650M/T,
- •ii. FGFR3 gene fusion or FGFR3 rearrangement is confirmed based on the
- •following genomic criteria:
- •(1) Any fusion/rearrangement with a literature-derived known partner
- •gene regardless of strand or frame.
- •(2) Fusion/rearrangements in the same strand that are in frame with a
- •novel partner gene.
- •(3) Fusion/rearrangements with one breakpoint in the intron 17 - exon
- •18 hotspot region and the other breakpoint in an intergenic region or
- •another gene. This rule excludes 3* duplications comprising only exon
- •iii. The amino acid numbers for the FGFR3 mutations refer to the
- •functional FGFR3 isoform 1 (NP_000133.1) that is the NCBI Refseq ID
- •used to report genetic alterations in FGFR3 by the FoundationOne® CDx
- •test (F1CDx, Foundation Medicine, USA).
- •iv. Written documentation of central laboratory determination by F1CDx
- •testing of FGFR3 alterations is required for study eligibility.
- •v. For subjects who require molecular prescreening to confirm the
- •presence of the FGFR3 alteration to meet the inclusion criteria, a tumor
- •sample with a pathology report must be sent to Foundation Medicine
- •USA for F1CDx testing. (Instructions for optimal tumor specimens are
- •provided in the protocol).
- •(1) The tumor sample to be used should be from the definitive surgical
- •resection (cystectomy, nephroureterectomy, or distal ureterectomy).
- •(2) An archival biopsy of confirmed invasive urothelial carcinoma (>=pT2)
- •can be used if (1) tissue from definitive surgery cannot be submitted, (2)
- •the biopsy sample is not older than 4 months prior to surgery date and
- •(3) the subject did not receive any type of systemic anticancer treatment
- •since the biopsy was obtained. If more than one biopsy is available, the
- •most recent one is to be sent.
- •b. If status post neoadjuvant chemotherapy, pathologic stage at surgical
- •resection must be Stage >= ypT2 and/or yN+. Prior neoadjuvant therapy
- •is defined as at least 3 cycles of neoadjuvant cisplatin-based
- •chemotherapy with a planned cisplatin dose of 70 mg/m2/cycle.
- •Subjects who received less than this or non-cisplatin-based neoadjuvant
- 另有 3 项未显示
排除标准
- •1. Presence of positive invasive surgical margins following
- •nephroureterectomy, distal ureterectomy, or cystectomy. In subjects not
- •eligible for further surgery, radiotherapy, or other efficacious treatment,
- •microscopic positive noninvasive margins (eg, carcinoma in situ) without
- •gross residual disease are allowed.
- •2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical
- •therapy for nonmuscle invasive bladder cancer (NMIBC) within the
- •previous 30 days.
- •3. Are currently receiving or are planning to receive during participation
- •in this study, treatment with agents that are known moderate or strong
- •inducers or inhibitors of CYP3A4 and medications which increase serum
- •phosphorus and/or calcium concentration. Subjects are not permitted to
- •receive enzyme-inducing antiepileptic drugs, including carbamazepine,
- •phenytoin, phenobarbital, and primidone. Prior anticancer or other
- •therapies are restricted as follows:
- •a. Prior adjuvant treatment for urothelial cancer is not allowed.
- •b. Prior neoadjuvant therapy (eg, chemotherapy, immunotherapy, or
- •investigational) is allowed if inclusion criterion #4 is met. Prior
- •neoadjuvant chemotherapy must have been completed within a period of
- •time that is greater than the cycle length used for that treatment before
- •the first dose of study drug.
- •c. Prior biologic, immunotherapy, or investigational therapy should have
- •been completed within a period that is >=5 half-lives or 30 days,
- •whichever is shorter, before the first dose of study drug.
- •4. Are planning to receive other systemic therapies intended to treat
- •invasive urothelial carcinoma while on this study.
- •5. Have previously or currently is receiving treatment with a mitogenactivated
- •protein kinase (MEK) or selective FGFR inhibitor.
- •6. Have a history of primary malignancy within the past 3 years other
- •than (1) invasive UBC or UTUC (ie, disease under study), (2) noninvasive
- •urothelial carcinoma, (3) any adequately treated in situ carcinoma or
- •non-melanoma carcinoma of the skin, (4) any other curatively treated
- •malignancy that is not expected to require treatment for recurrence
- •during participation in the study, or (5) an untreated cancer on active
- •surveillance that may not affect the subject's survival status for >=3
- •years based on clinician assessment/statement and with medical
- •monitor approval. For any other cancers that do not meet the criteria
- •above, and for which the natural history or treatment do not have the
- •potential to interfere with the safety or the efficacy assessments of the
- •study, written approval is required by the medical monitor.
- •7. Have current evidence of corneal keratopathy or retinal disorder
- •including, but not limited to, bullous/band keratopathy, inflammation or
- •ulceration, keratoconjunctivitis, macular degeneration, or diabetic
- •retinopathy, 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, vasculature, myocardium, and lung with the exception of
- •calcified lymph nodes, minor pulmonary parenchymal calcifications,
- 另有 2 项未显示
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