A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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