NCT07822880尚未招募4 期
A Phase 4, Single-Arm Study to Evaluate the Safety of Selpercatinib in Participants With RET-Altered Cancers in India
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)
研究概览
简要总结
This study will evaluate the safety of selpercatinib in participants with RET-altered cancers in India. The study will also assess the number of changes and why participants stop study treatment.
For each participant, the study is expected to last 56 weeks and will include up to 16 protocol-specific visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with one of the following RET-altered cancers:
- •Adults with advanced RET fusion-positive Non-small cell lung cancer (NSCLC) who require systemic therapy
- •Adults and pediatric participants (greater than or equal to 12 years) with advanced RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy
- •Adults and pediatric participants (greater than or equal to 12 years) with advanced RET fusion-positive thyroid cancer who require systemic therapy, or
- •Adults and pediatric participants (greater than or equal to 12 years) with advanced or metastatic RET fusion-positive solid tumors with disease progression on or after prior systemic therapies or who have no satisfactory therapeutic options
- •RET gene fusion or mutation in tumor identified using polymerase chain reaction (PCR) or next-generation sequencing (NGS)
- •Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening
- •Eastern Cooperative Oncology Group performance status score of 0 to 2
- •Have not received more than 1 cycle of first-line non-targeted therapy
- •Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 2 weeks following the last dose of study drug
- •Must have adequate organ function, as defined in the protocol.
排除标准
- •Additional validated oncogenic drivers in NSCLC if known OR have additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment.
- •Symptomatic central nervous system metastases, carcinomatous meningitis, or untreated spinal cord compression.
- •Clinically significant active cardiovascular disease or history of heart attack within 6 months, history of Torsades de Pointes, or prolongation of the QTcF >470 milliseconds on more than 1 electrocardiogram (ECG) during screening.
- •History of human immunodeficiency virus (HIV)
- •Active hepatitis B (HBV) or C (HVC)
- •Active uncontrolled systemic bacterial, viral or fungal infection or serious ongoing incurrent illness (such as high blood pressure or diabetes, interstitial lung disease)
- •Uncontrolled, disease related, pericardial effusion, or pleural effusion
- •Uncontrolled symptomatic overactive or underactive thyroid
- •Uncontrolled symptomatic high or low levels of calcium in the blood
- •Active hemorrhage or at significant risk for hemorrhage
- •Active malabsorption syndrome or other conditions likely to affect gastrointestinal (GI) absorption of study drug
- •Other malignancy unless non-melanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers, or malignancy diagnosed greater than or equal to 2 years previously and not currently active. Participants receiving adjuvant hormone therapy for breast cancer or prostate cancer with no evidence of disease are eligible. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.
- •History of receiving any RET-inhibitor treatment
- •Are participants who are contraindicated for the use of selpercatinib
- •Are pregnant or intend to become pregnant or breastfeed during the study
研究组 & 干预措施
Selpercatinib
Experimental
Administered orally
干预措施: Selpercatinib (Drug)
结局指标
主要结局
Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)
时间窗: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
次要结局
- Number of Participants Undergoing Dose Modification(Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days))
- Number of Adverse Events (AEs) Leading to Discontinuation of Study Intervention(Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days))
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
A Phase 1/2 study on the effects of LOXO-292 (study drug) in patients with advanced solid tumors.2023-507702-13-00Loxo Oncology Inc.128
进行中（未招募）
3 期
Selpercatinib 治疗 RET 突变甲状腺髓样癌患者 3 期试验RET 突变型甲状腺髓样癌CTR20192718Eli Lilly and Company/
Quotient Sciences - Philadelphia, LLC/
美国礼来亚洲公司上海代表处
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib versus Adjuvant Platinum-Based Chemotherapy in Patients with Completely Resected Stage Ib (tumors ≥ 4 cm) to Stage IIIa Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer2023-506861-76-00F. Hoffmann-La Roche AG55
招募中
3 期
A Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab (LIBRETTO-431)2023-506783-14-00Eli Lilly & Co.42
招募中
2 期
A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT07637578SCRI Development Innovations, LLC46