CTRI/2019/09/021092 [Registered on: 06/09/2019] Trial Registered Prospectively
Last Modified On:
19/08/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Single Arm Study
Public Title of Study
A study of INTP26 (trastuzumab) in patients with breast cancer or gastric cancer.
Scientific Title of Study
A multicentric, open label, single arm study to evaluate the safety and efficacy of INTP26
(trastuzumab biosimilar) in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
0566-18, Version no. 1.1, Date: 04 Jun 2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Prashant Modi
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway, Gota Ahmadabad GUJARAT 382481 India
Lambda House, Department of CTM Medical Services, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Public Query
Name
Mr Prashant Modi
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway, Gota Ahmadabad GUJARAT 382481 India
The Institutional Ethics Committee, Dr A P J Abdul Kalam Education and Research Centre and Superspeciality Dental Clinic, Dr. S H Advani
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,
Intervention / Comparator Agent
Type
Name
Details
Intervention
INTP26 of Intas Pharmaceuticals Limited, India
Dose: 150 mg/vial and 440 mg/vial; Frequency: 6 cycles (3-weekly regimen) or 18 cycles (weekly regimen); Mode of Administration: Intravenous; Duration of treatment: 24 weeks
Comparator Agent
NA
NA
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Adults ≥18 years old.
2. HER2-positive metastatic breast cancer (patients either previously treated or not previously treated for their metastatic disease), OR HER2-positive early breast cancer, OR HER2-positive metastatic adenocarcinoma of stomach or gastroesophageal junction adenocarcinoma who have not received prior
anti-cancer treatment for their metastatic disease
Note:
HER2-positive is defined as:
o Immunohistochemistry (IHC) score of 3+ (IHC score of 2+ will be considered if FISH test is positive for HER2 receptor)
or
Fluorescence in situ hybridization (FISH) test positive for HER2 receptor.
In case of early breast cancer, eligible patients receiving neoadjuvant or adjuvant therapy will be eligible.
Patients who have received trastuzumab in neoadjuvant or adjuvant setting will be allowed for adjuvant / metastatic setting in the study.
3. Patient should be eligible for trastuzumab treatment as per the approved prescribing information of the product.
4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria
Note: Measurable lesion criteria is not applicable for patients eligible for adjuvant therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
6. Normal left ventricular ejection fraction as per ECHO.
7. Understands the content of the protocol (including use of acceptable contraception during the study and until 6 months after the last dose of Trastuzumab), willing to provide informed consent and comply with protocol requirements.
ExclusionCriteria
Details
1. For females, a positive pregnancy test at screening or women who are lactating.
2. Males or WOCBP not willing to follow appropriate contraceptive measures during the course of study.
3. Known to have tested positive for HIV, HCV or HBsAg.
4. History of hypersensitivity to trastuzumab
5. Currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug trial(s), or patient is receiving another investigational agent(s).
6. History of substance abuse, including chronic alcoholism.
7. Life expectancy of less than 12 months.
8. Patients with NYHA Grade II (or more severe) congestive heart failure, clinically significant cardiac diseases (like, unstable angina pectoris, angina pectoris requiring treatment, myocardial infarction, valvular
disease, cardiac arrhythmia) , cerebral infarction or transient ischemic attacks.
9. Uncontrolled hypertension even with treatment (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac
arrhythmias even with treatment (Patients with hypertension or arrhythmia controlled by therapies are eligible).
10. History of renal, hepatic, lung, immunological or haematological diseases that may affect patient safety as per the investigator.
11. Patients having active severe infections e.g., tuberculosis, sepsis and opportunistic infections.
12. Patients with brain metastasis.
13. Any of the following abnormal investigational values
a. General: Any laboratory abnormality, which, in the opinion of the Investigator, would prevent the patient from completing the study or interfere with the interpretation of the study results.
b. Liver transaminases:
i. Serum aspartate aminotransferase (AST; serum glutamateoxaloacetic transaminase [SGOT]) ≥2 × upper limits of normal [ULN];
ii. Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) ≥2.0 × ULN Alkaline phosphatase and bilirubin ≥1.5 × ULN (isolated bilirubin ≥1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin 35%)
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Safety of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.
Throught the study
Secondary Outcome
Outcome
TimePoints
Efficacy of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.
Screening, and at 6, 12 and
18 weeks
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
25/09/2019
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None Yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Breast cancer is one of the most occurring cancers globally and in India as well, with incidence rate of 25.2% for the world and 27% for India. Among all breast cancer patients, human epidermal growth factor receptor 2 (HER2) overexpression or amplification occurs in approximately 20% to 25% of patients and is associated with aggressive disease and decreased survival. Gastric cancer is the second-most common cancer among men and third-most among women in Asia and worldwide. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. Intas has planned this Phase IV, non-comparative study to assess the safety and efficacy of INTP26 in patients with HER2-overexpressing breast (early and metastatic) and metastatic gastric cancer. This study fulfils the recommendation received from DCGI along with the marketing approval. This is a single arm, multicenter, Phase IV clinical trial. This will be a non-randomized study. Eligible patients will receive INTP26 for a total of 6 cycles (3 weekly regimen) or 18 cycles (weekly regimen). Approximately 200 patients will be included in the study assuming that it will be sufficient to meet the study objective.