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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Participants will receive a single dose of trastuzumab 600 mg SC separately, co-mixed or co-formulated with pertuzumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration from Time Zero to Time Infinity (AUC0-inf) of Pertuzumab SC | 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 | 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 | 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) | |
| Minimum Serum Concentration (Cmin) of Pertuzumab SC | 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 | 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 | 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) | |
| Tmax of Pertuzumab IV | 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) | |
| Cmin of Pertuzumab IV |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Baseline up to approximately 24 months | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies | Auckland | 1142 | New Zealand | |||
| Christchurch Clinical Studies Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30570763 | Derived | Kirschbrown WP, Wynne C, Kagedal M, Wada R, Li H, Wang B, Nijem I, Badovinac Crnjevic T, Gasser H, Heeson S, Eng-Wong J, Garg A. Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study. J Clin Pharmacol. 2019 May;59(5):702-716. doi: 10.1002/jcph.1362. Epub 2018 Dec 19. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| Pertuzumab | Drug | Participants will receive pertuzumab as a single agent injection, co-mixed or formulated as FDC with trastuzumab depending upon cohort. The dose will range from 400 to 1200 mg. |
|
|
| 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) |
| 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 ATAs to rHuPH20 | Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall) |
| Christchurch |
| 8011 |
| New Zealand |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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