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临床试验/NCT02738970
NCT02738970已完成1 期

A Phase I, Open-Label, Two-Part, Multicenter Perjeta® Subcutaneous Dose-Finding Study in Combination With Herceptin® in Healthy Male Volunteers and Female Patients With Early Breast Cancer

Hoffmann-La Roche2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年6月23日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
88
试验地点
2
主要终点
Tmax of Pertuzumab IV
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Part 1: Healthy male volunteers 18 to 45 years of age
  • •Part 1: Left ventricular ejection fraction (LVEF) at least 55 percent (%)
  • •Part 1: Body mass index (BMI) 18 to 32 kilograms per meter-squared (kg/m^2)
  • •Part 1: Normal, intact skin without tattoos or lesions in the injection area
  • •Part 2: Females at least 18 years of age
  • •Part 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0
  • •Part 2: Previously treated, non-metastatic carcinoma of the breast
  • •Part 2: Baseline LVEF at least 55%
  • •Part 2: Negative pregnancy test and use of adequate contraceptive measures among women of childbearing potential

排除标准

  • •Part 1: Positive urine test for drugs of abuse
  • •Part 1: History of exposure or active viral infection of Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • •Part 1: Cardiac disease including hypertension or hypotension
  • •Part 1: Lower extremity edema
  • •Part 1: Any clinically relevant history of systemic disease
  • •Part 1: History of breast cancer
  • •Part 1: Chronic corticosteroid use
  • •Part 1: Receipt of IV antibiotics within 7 days prior to enrollment
  • •Part 2: Concurrent malignancy requiring therapy that may interfere with pharmacokinetic investigations, or history of other malignancy within 5 years prior to Screening
  • •Part 2: Significant cumulative exposure to anthracyclines
  • •Part 2: Serious cardiac disease including uncontrolled hypertension
  • •Part 2: Poor hematologic, renal, or hepatic function
  • •Part 2: Pregnant or lactating women
  • •Part 2: History of exposure or active viral infection of Hepatitis B, hepatitis C, or HIV
  • •Part 2: Chronic corticosteroid use
  • •Part 2: Receipt of IV antibiotics within 7 days prior to enrollment

研究组 & 干预措施

Part 1-Cohort 1: Pertuzumab 420 Milligrams (mg) IV

Active Comparator

Part 1 includes healthy male participants. Participants will receive a single injection of pertuzumab 420 mg IV.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 2: Pertuzumab 400 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of pertuzumab 400 mg SC.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 3: Pertuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of pertuzumab 600 mg SC.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 4: Pertuzumab 1200 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of pertuzumab 1200 mg SC.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 5: Trastuzumab 600 mg SC

Active Comparator

Part 1 includes healthy male participants. Participants will receive a single injection of trastuzumab 600 mg SC.

干预措施: Trastuzumab (Drug)

Part 1-Cohort 6: Pertuzumab 400 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 400 mg and trastuzumab 600 mg SC.

干预措施: Trastuzumab (Drug)

Part 1-Cohort 6: Pertuzumab 400 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 400 mg and trastuzumab 600 mg SC.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 7: Pertuzumab 1200 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 1200 mg and trastuzumab 600 mg SC.

干预措施: Trastuzumab (Drug)

Part 1-Cohort 7: Pertuzumab 1200 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 1200 mg and trastuzumab 600 mg SC.

干预措施: Pertuzumab (Drug)

Part 1-Cohort 8: Pertuzumab 1200 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 1200 mg and trastuzumab 600 mg SC without recombinant human hyaluronidase (rHuPH20) excipient.

干预措施: Trastuzumab (Drug)

Part 1-Cohort 8: Pertuzumab 1200 mg SC + Trastuzumab 600 mg SC

Experimental

Part 1 includes healthy male participants. Participants will receive a single injection of co-mixed pertuzumab 1200 mg and trastuzumab 600 mg SC without recombinant human hyaluronidase (rHuPH20) excipient.

干预措施: Pertuzumab (Drug)

Part 2-Cohort A: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohort A will be enrolled only if FDC of pertuzumab and trastuzumab is not feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC administered separately. The dose of pertuzumab will be identified during Part 1.

干预措施: Trastuzumab (Drug)

Part 2-Cohort A: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohort A will be enrolled only if FDC of pertuzumab and trastuzumab is not feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC administered separately. The dose of pertuzumab will be identified during Part 1.

干预措施: Pertuzumab (Drug)

Part 2-Cohort B: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohorts B and C will be enrolled if FDC of pertuzumab and trastuzumab is feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC; both agents administered in one injection (co-mixed). The dose of pertuzumab will be identified during Part 1.

干预措施: Trastuzumab (Drug)

Part 2-Cohort B: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohorts B and C will be enrolled if FDC of pertuzumab and trastuzumab is feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC; both agents administered in one injection (co-mixed). The dose of pertuzumab will be identified during Part 1.

干预措施: Pertuzumab (Drug)

Part 2-Cohort C: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohorts B and C will be enrolled if FDC of pertuzumab and trastuzumab is feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC; both agents formulated together and administered in one injection (FDC). The dose of pertuzumab will be identified during Part 1.

干预措施: Trastuzumab (Drug)

Part 2-Cohort C: Pertuzumab SC + Trastuzumab SC

Experimental

Part 2 includes women with early breast cancer. Cohorts B and C will be enrolled if FDC of pertuzumab and trastuzumab is feasible. Participants will receive pertuzumab and trastuzumab (600 mg) SC; both agents formulated together and administered in one injection (FDC). The dose of pertuzumab will be identified during Part 1.

干预措施: Pertuzumab (Drug)

结局指标

主要结局

Tmax of Pertuzumab IV

时间窗: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)

Area Under the Concentration from Time Zero to Time Infinity (AUC0-inf) of Pertuzumab SC

时间窗: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)

Maximum Serum Concentration (Cmax) of Pertuzumab SC

时间窗: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)

Time to Reach Cmax (Tmax) of Pertuzumab SC

时间窗: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)

Cmin of Pertuzumab IV

时间窗: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)

Minimum Serum Concentration (Cmin) of Pertuzumab SC

时间窗: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)

AUC0-inf of Pertuzumab IV

时间窗: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)

Cmax of Pertuzumab IV

时间窗: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)

次要结局

  • Percentage of Participants with ATAs to Trastuzumab(Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall))
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Pertuzumab(Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall))
  • Percentage of Participants with Adverse Events(Baseline up to approximately 24 months)
  • Percentage of Participants with ATAs to rHuPH20(Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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