Metastatic Breast Cancer Clinical Trial
Official title:
Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
Verified date | April 2017 |
Source | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
Status | Completed |
Enrollment | 89 |
Est. completion date | October 27, 2017 |
Est. primary completion date | October 27, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration; - Healthy male subjects aged = 18 years and = 65 years; - Body weight = 50 kg = 90 kg, body mass index = 18 = 28kg/m2; - The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance; - Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion. Exclusion Criteria: - History of hypertension or abnormal blood pressure at screening/baseline measurement; - A history of albuminuria or albuminuria as assessed by the investigator as clinically significant; - Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year; - Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months; - Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding; - History of digestive tract perforation or digestive tract fistula; - Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion; - Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use; - Positive virology test; - Known allergy to trastuzumab; - Known history of allergic diseases or allergic constitution; - Study the history of blood donation 3 months before drug infusion; - Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening - A history of alcohol or drug abuse in the 12 months prior to screening; - A history of mental illness; - Subjects whose spouses plan to become pregnant; - The study cannot be completed according to protocol requirements during the study period; - Conditions considered unsuitable for inclusion by other researchers. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under drug concentration - time curve (AUC0-t) | Area under the curve from time zero to the lowest detectable blood drug concentration | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | Area under drug concentration - time curve (AUC0-8) | The area under the curve extrapolating from time zero to infinity | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | Peak concentration (Cmax) | Peak maximum plasma drug concentration | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | Time to reach maximum plasma (Tmax) | Time to reach maximum plasma concentration after dosing | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | Clearance (CL) | Percentage of the body that eliminates organ-scavenging drugs | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | half-life (T1/2) | The time it takes for serum drug concentrations to drop by half | Within 30 minutes before administration to 1344 hours after administration | |
Secondary | Apparent volume of distribution (Vd/F) | Apparent volume of distribution after administration | Within 30 minutes before administration to 1344 hours after administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04872608 -
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT02506556 -
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05534438 -
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03368729 -
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04103853 -
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Active, not recruiting |
NCT03147287 -
Palbociclib After CDK and Endocrine Therapy (PACE)
|
Phase 2 | |
Not yet recruiting |
NCT06062498 -
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |