2024-514180-25-00招募中3 期
C4251008 - An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Seagen Inc.
- 入组人数
- 155
- 试验地点
- 111
- 主要终点
- PFS per BICR is defined as the time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
研究概览
简要总结
To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) according to blinded independent central review (BICR) assessment between treatment arms
研究设计
- 分配方式
- Randomized
- 主要目的
- A Study Of Tucatinib With Trastuzumab And M Folfox6 Vs Soc Treatment In First-line Her2+ M Crc
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Have histologically and/or cytologically documented adenocarcinoma of the colon or rectum, which is locally advanced unresectable or metastatic
- •Participants must be willing and able to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks obtained prior to treatment initiation, to a sponsor-designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to the Cycle 1 Day 1 timeframe. Biopsy must provide adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.
- •Have HER2+ disease as determined by tissue-based investigational HER2 IHC and ISH assays performed at a sponsor-defined central laboratory. HER2 amplification will be determined using ASCO/CAP guidelines for gastric and gastroesophageal cancer with IHC 3+ or IHC 2+/ISH+ result.
- •Have RAS WT disease as determined by local or central testing. Central testing may only be used with Medical Monitor approval if local testing is not available or when otherwise deemed necessary. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
- •Have radiographically measurable disease per RECIST v1.1 according to INV assessment, with at least one site of disease that is measurable and that has not been previously irradiated; or, if the subject has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- •Have ECOG Performance Status (PS) of 0 or 1
- •CNS Inclusion: a. No evidence of brain metastases; b. Previously treated brain metastases which are asymptomatic.
排除标准
- •Have previously received any systemic anticancer therapy for CRC in the metastatic setting or have participated in any interventional clinical trial for CRC in the metastatic setting; note that subjects may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization. Participants may have received prior chemotherapy for CRC in the adjuvant setting provided that it was completed >6 months prior to enrollment.
- •Have previously received radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of SRS). SubjectsParticipants who have received prior radiation therapy must have recovered to baseline from any treatment-related adverse events (AEs). Participants Subjects who have received palliative radiotherapy for symptomatic metastases may enter the study without a washout period provided that the subject has recovered from any treatment-related AEs.
- •Have previously been treated with anti-HER2 therapy
- •Have ongoing ≥ Grade 2 diarrhea of any etiology
- •Inability to swallow pills or any significant GI disease which would preclude the adequate oral absorption of medications
- •Participants with active CNS metastases (irradiated or resected lesions are permitted). See Inclusion Criteria for details. Participants with carcinomatous meningitis are excluded without exception.
结局指标
主要结局
PFS per BICR is defined as the time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
PFS per BICR is defined as the time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
次要结局
- OS, defined as time from randomization to death from any cause (key secondary endpoint)
- cORR per BICR is defined as the proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by BICR. (key secondary endpoint)
- PFS per INV is defined as time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
- cORR per INV is defined as the proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators.
- DOR is defined as time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs earlier.
- DOR per investigator is based on investigator response assessment and DOR per BICR is based on BICR response.
- Time to second progression or death (PFS2) is defined as the time from randomization to disease progression on the next-line of therapy, or death from any cause, whichever occurs first
- Individual plasma tucatinib concentrations will be used for PK assessments
- Change from baseline will be measured for the following PROs scales: global health status/QoL (EORTC QLQ-C30 items 29 and 30) and physical functioning (EORTC QLQ-C30 items 1-5) and time to meaningful change, defined as the time from baseline to the first onset of a ≥10-point changes from baseline in global health status/QoL (EORTC QLQ-C30 items 29 and 30), physical functioning (EORTC QLQ-C30 items 1-5)
研究者
Clinical Medical Lead
Scientific
Seagen Inc.
研究点 (111)
Loading locations...
相似试验
招募中
2 期
A research study to investigate the safety of setanaxib and helpfulness in the treatment of recurrent or metastatic squamous cell carcinoma of the
head and neck (SCCHN)2023-509917-35-00Calliditas Therapeutics Suisse S.A.48
招募中
4 期
Mirvetuximab soravtansine in combination with bevacizumab for the maintenance treatment of adult patients with FRα-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed on platinum-based chemotherapy2022-501606-35-01Immunogen Biopharma (Ireland) Limited, Immunogen Inc.110
招募中
2 期
Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer.2024-514395-40-00Fundacion Grupo Espanol De Investigacion En Cancer De Mama200
招募中
3 期
A study to learn more about how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations of the human epidermal growth factor receptor 2 (HER2)2024-511319-91-00Bayer AG145
招募中
3 期
Extension Study for Participants in Studies That Include Pembrolizumab2022-501254-10-00Merck Sharp & Dohme LLC1,133