NCT04798781已完成2 期
A Phase II Study Evaluating Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
Andrew Hendifar, MD3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年7月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Progression-free Survival
研究概览
简要总结
This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. OR: Hepatocellular carcinoma with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
- •At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and be documented by radiological evaluation within 28 days prior to registration. For subjects with locally advanced disease: at least one measurable lesion that has not been irradiated, documented by radiological evaluation within 28 days prior to registration.
- •Any prior radiation therapy must be completed at least 28 days prior to the first dose of study treatment.
- •Eighteen years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or
- •Adequate bone marrow, liver, and renal function
- •Negative urine or serum pregnancy test for women of childbearing potential.
- •Women and men of childbearing potential must agree to use adequate contraception prior to registration, for the duration of study participation and until 4 months after the last study drug dosing.
- •Able to swallow tablets and agree to take the prescribed tablets twice daily.
排除标准
- •Clinical or radiographic evidence of current brain metastasis. History of treated brain metastases is allowable.
- •Cardiac disease
- •Uncontrolled hypertension
- •Severe hemorrhage/bleeding event within 28 days prior to the first dose of study treatment
- •Major surgery, open biopsy, or significant traumatic injury within 42 days prior to the first dose of study treatment
- •Current serious, nonhealing wound, ulcer, or bone fracture within 42 days prior to the first dose of study treatment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment.
- •Presence of an uncontrolled infection or infection that required intravenous antibiotics, antifungals, or antivirals within 14 days prior to the first dose of study treatment.
- •Known human immunodeficiency virus (HIV) infection. HIV-infected subjects on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. The safety of telatinib in this subject population has not been studied.
- •Known chronic hepatitis B, unless receiving antiviral treatment.
- •Known Child-Pugh Score B or C liver cirrhosis.
- •Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment or has been diagnosed with an autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine [T4], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.
- •History of (non-infectious) pneumonitis that required steroids, or current pneumonitis, or has a history of interstitial lung disease.
- •Has received a live-virus vaccination within 30 days of planned treatment start.
- •Known history of proteinuria > 1gr/24 hours.
- •Previous or concurrent cancer that is distinct in primary site or histology from the current stomach or liver cancer. Subjects with cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated are not excluded.
- •Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent within 28 days prior to the first dose of study treatment.
- •Known or suspected allergy to any component of telatinib or Keytruda
- •Prior or current history of substance abuse, or medical, psychological, or social condition that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study result.
- •Women who are pregnant or breastfeeding.
- •Prior history of thromboembolic disease, e.g., deep vein thrombosis (DVT), pulmonary emboli (PE), within 6 months prior to the first dose of study treatment that has required continued medical intervention.
- •Baseline peripheral neuropathy.
研究组 & 干预措施
telatinib + Keytruda
Experimental
干预措施: Telatinib (Drug)
telatinib + Keytruda
Experimental
干预措施: Keytruda (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: through study completion, approximately 2.5 years
Duration of time from start of treatment until progression or death, whichever comes first
次要结局
- Overall Response Rate(from the start of treatment until the end of treatment, approximately 12 months)
- Disease Control Rate(from the start of treatment until the end of treatment, approximately 12 months)
- Overall Survival(from the start of treatment until time-of-event)
- Number and Severity of Adverse Events(from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months)
研究者
Andrew Hendifar, MD
Assistant Professor, Medicine
Cedars-Sinai Medical Center
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Azacitidine, Lenalidomide and DLI as Salvage Therapy for MDS, CMML and sAML Relapsing After Allo-HSCTLeukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicNCT02472691Heinrich-Heine University, Duesseldorf50
招募中
2 期
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast CancerTriple-Negative Breast CancerNCT06492005Mabwell (Shanghai) Bioscience Co., Ltd.160
已完成
2 期
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular CarcinomaHepatocellular CarcinomaNCT05864105Biotheus Inc.35
进行中（未招募）
1 期
BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell DiseaseSickle Cell DiseaseNCT05456880Beam Therapeutics Inc.15
Unknown
2 期
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 PositiveCervical CancerNCT03808857Genor Biopharma Co., Ltd.80