Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.

March 19, 2022 updated by: Nanogen Pharmaceutical Biotechnology Joint Stock Company

Randomized, Single-blind, Multicenter, Parallel Group Clinical Trial to Assess Pharmacokinetic Parameters, Safety of NNG-TMAB (Trastuzumab) in Combination With Docetaxel on Recurrent or Metastatic Breast Cancer Patients With Positive HER2.

Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal growth factor Receptor). HER2 receptor plays an important role in cell growth and differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive malignance exacerbates pathology and worsens clinical outcome, such as shortened overall survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30% overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression tumor have disease progression and poor prognosis in metastatic process (8), (9).

Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth of cancer cells has been approved. One of these products is Trastuzumab.

The study processed on 50 females aged between 18 and 65, recurrent or metastatic breast cancer patients with positive HER2.

The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® + docetaxel, in blocks of 4 in a 1:1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be 2 patients in the experimental group and 2 patients in the control group.

Primary endpoint is serum peak concentrations (Cmax), area under the curve from 0 to t (AUC0-t).

This trial is intended to assess the biosimilarity of pharmacokinetic parameters, safety between Faceptor (experimental drug) and Herceptin (reference).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • 19-8 Hospital
      • Ho Chi Minh City, Vietnam
        • Hcmc Oncology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients from 18 to 65 years old.
  • Willing to give written and signed informed consent.
  • Have pathologically or cytologically confirmed breast cancer.
  • Inoperable, recurrent or metastatic breast cancer according to TNM classification and investigator' s assessment.
  • Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial.
  • Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH).
  • Eastern Cooperative oncology group performance status ≤ 2
  • Willing to comply the requirements of the study protocol.
  • Have a survival expectancy of at least 6 months.
  • At screening period: Hb ≥ 9 g/dL; Neutrophils ≥ 1,5x10^9/L; platelets ≥ 100x10^9/L; creatinine level ≤ 1,5 x upper limit of normal (ULN); bilirubin level < 1,5 x ULN; ALT/AST < 2,5 x ULN (< 5 x ULN for patients with liver metastases), ALP < 5 x ULN.
  • Patients of childbearing potential and her partner must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug

Exclusion Criteria:

  • Previous anticancer therapy for metastatic BC, including previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous chemotherapy or hormonal therapy is allowed.
  • Previously treated with doxorubicin > 400 mg/m2; epirubicin > 800 mg/m2 in accumulative dosages.
  • Surgery, radiation therapy, use of any experimental medications within 4 weeks prior to randomization.
  • Clinical evidence or X-ray show that breast cancer metastases in central nervous system
  • Patients with metastatic tumor to the bone is the only tumor to be measured
  • Systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg. Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise)
  • Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization. LVEF < 50% according to echocardiogram when screening.
  • Acute or chronic infection (except for acute or chronic infection that is stable and does not affect the study evaluation). Infecting HIV, HBV or HCV, Syphilis
  • Patients with a history of severe allergic reaction to trastuzumab, paclitaxel, docetaxel or other ingredients in the formulation
  • The patient has evidence of a serious illness (such as resting dyspnea or severe lung disease, etc.) or an abnormal laboratory test that, in the judgment of the researcher, will affect participation. research and completion of patient research, or may affect the patient's response evaluation.
  • Pregnancy, intend to get pregnant, lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Faceptor + Docetacel
Patients received a loading dose of Faceptor 8 mg/kg IV + docetaxel 75 mg/m^2 IV on Cycle 1 followed by Faceptor 6 mg/kg IV + docetaxel 75 mg/m^2 IV on the next 5 cycles (each cycle is 21 days)
Drug: Faceptor
NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.
Other Names:
  • NNG-TMAB
  • Trastazumab
Drug: Docetaxel
The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.
Other Names:
  • Taxotere
Active Comparator: Herceptin + Docetacel
Patients received a loading dose of Herceptin 8 mg/kg IV + docetaxel 75 mg/m^2 IV on Cycle 1 followed by Herceptin 6 mg/kg IV + docetaxel 75 mg/m^2 IV on the next 5 cycles (each cycle is 21 days)
Drug: Docetaxel
The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.
Other Names:
  • Taxotere
Drug: Herceptin
Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.
Other Names:
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters: Cmax
Time Frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Serum peak concentrations (Cmax)
Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Pharmacokinetic parameters: AUC0-t
Time Frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Area under the curve from 0 to t (AUC0-t)
Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters: Ctrough
Time Frame: Blood samples will be collected at following time points: day 23rd, 65th, 107th and 128th (at the beginning of visits 4, 8, 12, 14)
Serum trough concentration (Ctrough)
Blood samples will be collected at following time points: day 23rd, 65th, 107th and 128th (at the beginning of visits 4, 8, 12, 14)
Pharmacokinetic parameters: AUC0-∞
Time Frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Area under the curve from 0 to ∞ (AUC0-∞)
Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Pharmacokinetic parameters: Tmax
Time Frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Time for the drug to reach peak concentration (Tmax)
Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Pharmacokinetic parameters: T1/2
Time Frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Half-life (T1/2)
Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1
Rate of AE and SAE occurence
Time Frame: up to 128 days (6 cycles - each cycle is 21 days)
Frequency of adverse events, including clinical examination, vital signs and laboratory tests.
up to 128 days (6 cycles - each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

Collaborators

Vietstar Biomedical Research
MedProve Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

February 19, 2021

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 19, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNG17.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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