| CTRI Number |
CTRI/2021/09/036766 [Registered on: 23/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Combinatorial therapy of antibody and anticancer drug vs monotherapy of either agent against a type of cancer (KRAS mutated) |
|
Scientific Title of Study
|
A Prospective, randomized, open label, study to determine the safety and efficacy of Group- I - AB001 Alone, Group – II – AB001 + Chemotherapy and Group – III – Chemotherapy Alone in patients with Triple Negative Breast Cancer(TNBC) and KRAS mutated Cancer. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sathish Kumar |
| Designation |
Director and Consultant |
| Affiliation |
Mohans Medicity Multispecality hospital |
| Address |
Mohans Medicity Multispecality Hospital 11 A vinayaga Nagar opp District Court KK Nagar Madurai
Mohans Medicity Multispecality Hospital 11 A vinayaga Nagar opp District Court KK Nagar Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
|
| Fax |
|
| Email |
drmsathishkumar924@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh |
| Designation |
Independent Director |
| Affiliation |
Vopec Pharmaceuticals Pvt Ltd |
| Address |
B13 Mogappair Industrial Estate Mogappair West Chennai Tamil Nadu 600037
B13 Mogappair Industrial Estate Mogappair West Chennai Tamil Nadu 600037
Chennai
TAMIL NADU
600037
India |
| Phone |
|
| Fax |
|
| Email |
jusdinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Kumar |
| Designation |
Head Clinical Operations |
| Affiliation |
Ethos Clinical Research |
| Address |
F8 Rohini Gardens
MRC Nagar Raja Annamalaipuram Chennai
F8 Rohini Gardens
MRC Nagar Raja Annamalaipuram Chennai
Chennai
TAMIL NADU
600028
India |
| Phone |
04442022111 |
| Fax |
|
| Email |
kumarspani@hotmail.com |
|
|
Source of Monetary or Material Support
|
| VOPEC PHARMACEUTICALS PVT LTD |
|
|
Primary Sponsor
|
| Name |
Agastiya Biotech LLC |
| Address |
5256 South Mission Road Suite 132 Bonsall CA 92003 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| VOPEC PHARMACEUTICALS PVT LTD |
B13, Mogappair Industrial Estate Mogappair West Chennai Tamil Nadu 600037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Sathish Kumar |
Mohans Medicity Multispecality Hospital |
Director and Consultant in Dept of Oncology
Division of Oncology
Room No 101
11A vinayaga Naga opp District Court KK Nagar Tamil Nadu 625020
Madurai
TAMIL NADU |
9994021428
drmsathishkumar924@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SARAVANA MUTISPECALITY HOSPITAL - IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
ABOO1 |
(1E, 4E, 6E)-1-(3, 5-dimethoxyphenyl)- 7-(4-hydroxy-3,
5dimethoxyphenyl) hepta- 1, 4, 6-trien-3-one
Twice a Day (BD) Morning and Night, Route of Administration -Oral for 84 days |
| Intervention |
ABOO1 along with Chemotherapy |
(1E, 4E, 6E)-1-(3, 5-dimethoxyphenyl)- 7-(4-hydroxy-3,
5dimethoxyphenyl) hepta- 1, 4, 6-trien-3-one
ABOO1 - 400 mg Twice a Day (BD) Morning and Night, Route of Administration -Oral for 84 days along with Chemotherapy as per Principal Investigator Discretion by treating anticancer drugs like docetaxel,Paclitaxel,., etc on Day 1, Day 28, Day 56 and Day 84 of Intravenous infusion . |
| Comparator Agent |
Chemotherapy |
Chemotherapy as per Principal Investigator discretion by treating anticancer drugs like docetaxel,Paclitaxel,., etc on Day 1, Day 28, Day 56 and Day 84 of Intravenous infusion . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age–18 to70 years(female)
2.Patients with advanced Triple Negative Breast Cancer (TNBC) and KRAS mutated Cancer by testing (HER2, ER, PR and KRAS expression), not amenable to surgical therapy.
3.Eligible for taxane monotherapy.
4.No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic breast Cancer (TNBC).
5.Patients must have measurable disease on radiological imaging PET scan to monitor treatment response. Measurable disease, as defined by RECISTv1.1.
6.Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 5 months after the last dose of study drug, or for at least 6 months after the last dose of paclitaxel.
7.Life expectancy> 24 weeks
8.Patient should be willing to undergo all treatment related procedures and investigations
9.PatientshouldbewillingandreadyforPETScanand/orCTand/orUSGand/orMRIand follow-up scans
10.Patient is willing to take and to tolerate cytotoxic drugs
Willing to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1.Patients above 70yr sage
2.Pregnant or lactating women, or intending to become pregnant during the study.
3.Life threatening comorbidities suchas HIV, HPV, HBV, HCV, Tuberculosis ,CHF, Impaired Hepaticor Renal Function oranypsychological deficits etc.
4.Known CNS disease, except for treated asymptomatic CNS metastases.
5.Uncontrolled pleural effusion, pericardial effusion, orascites
6.Uncontrolled tumor-related pain
7.Significant cardiovascular disease, such as New York Heart As Standard of Careiation (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
8.Major surgical procedure within 4weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
9.History of autoimmune disease.
10.Prior allogeneic stem cell or solid organ transplantation
11.Poor peripheral venous access
Patients not suitable for study as per investigators opinion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Benefit Rate Complete Response (CR) with Partial Response (PR) with Stable Disease (SD) Tumor Reduction Time Frame Up to3months |
baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Best Overall Response (OR) Time Frame Up to3months
Duration of Overall Response Time Frame Up to 3 months
Progression Free Survival(PFS) Time Frame Up to3months
Safety evaluation
Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) Time Frame From Day 1 to last dose of study drug |
Secondary outcome: all-cause mortality at 1 year, 3 years), or may involve a different event, variable, or experience altogether. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "4"
Final Enrollment numbers achieved (India)="4" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/09/2021 |
| Date of Study Completion (India) |
20/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIl |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 09-09-2022 and end date provided 09-09-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This is an Academic P.I based study to a Prospective, randomized, open label, study to determine the safety and efficacy of Group- I - AB001 Alone, Group – II – AB001 + Chemotherapy and Group – III – Chemotherapy Alone in patients with Triple Negative Breast Cancer(TNBC) and KRAS mutated Cancer and to evaluate the antitumor activity of single-agent AB001measured by overall response rate (ORR) [ Time Frame: up to 3 months] as assessed by the best tumor response (complete response [CR] partial response [PR], stable disease, and progressive disease) during the study using Response Evaluation Criteria in Solid Tumors .
The study was completed with 04 Randomized subjects. |