JPRN-jRCT2031220134进行中（未招募）2 期
PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
Kawai Norisuke0 个研究点目标入组 320 人开始时间: 2022年6月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received prior CDK4/6 inhibitor in the advanced or metastatic setting)
- •*Participants with other advanced or metastatic solid tumor
- •*Have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated (expansion cohort only)
- •*Performance Status 0 or 1
- •*Adequate bone marrow, kidney and liver function
- •*Resolved acute effects of any prior therapy to baseline severity
排除标准
- •Exclusion Criteria:
- •* Participants with known symptomatic brain metastases requiring steroids
- •* Participants with any other active malignancy within 3 years prior to enrollment
- •* Major surgery within 3 weeks prior to study entry
- •* Radiation therapy within 3 weeks prior to study entry.
- •* Systemic anti cancer therapy within 4 weeks prior to study
- •* Prior irradiation to >25% of the bone marrow
- •* Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness
- •* COVID-19/SARS-CoV2
- •* Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- •* Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.
- •* Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.
- •* Hypertension that cannot be controlled by medications
- •* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.
- •* Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
- •* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
- •* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short
- •* Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally
- •* Previous high dose chemotherapy requiring stem cell rescue
- •* Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
- •* Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers
- •* Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic
- •* Serum pregnancy test positive at screening
- •* Other medical or psychiatric conditio
研究者
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