| CTRI Number |
CTRI/2014/01/004293 [Registered on: 07/01/2014] Trial Registered Prospectively |
| Last Modified On: |
06/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to know the safety, pharmacokinetics and anticancer activity of NRC-2694-A in patients with advanced cancers |
|
Scientific Title of Study
|
A Phase I Clinical Study to evaluate the safety, pharmacokinetics and anti-tumor activity of NRC-2694-A in patients with advanced Solid Malignancies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Raghunadharao |
| Designation |
Professor |
| Affiliation |
Nizam’s Institute of Medical Sciences |
| Address |
Dept. of Medical Oncology Nizam’s Institute of Medical Sciences Punjagutta
Dept. of Medical Oncology Nizam’s Institute of Medical Sciences Punjagutta
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
|
| Fax |
|
| Email |
telerama@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen C Myneni |
| Designation |
Medical Officer |
| Affiliation |
NATCO Pharma Limited |
| Address |
NATCO House Road No. 2, Banjara Hills
NATCO House Road No. 2, Banjara Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
919989025592 |
| Fax |
|
| Email |
clinical@natcopharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
G venkata Ramana |
| Designation |
Coordinator-Drug Development |
| Affiliation |
NATCO Pharma Limited |
| Address |
NATCO House Road No. 2, Banjara Hills
NATCO House Road No. 2, Banjara Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
919849034389 |
| Fax |
|
| Email |
gvramana@natcopharma.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NATCO Pharma Limited |
| Address |
Natco House Road No. 2 Banjara Hills Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Raghunadharao |
Nizams Institute of Medical Sciences |
Department of Medical Oncology
Nizams Institute of Medical Sciences Panjagutta Hyderabad
Hyderabad
ANDHRA PRADESH |
04023372947
telerama@rediffmail.com |
| Dr Kumar Prabhash |
Tata Memorial Centre |
Department of Medical Oncology
Clinical Research Center
I Floor
Khanolkar Shodhika-Room No. 102
Advanced Centre for Treatment Research and Education in Cancer
Sector No. 22
Kharghar, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA |
02224177214
kprabhash1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Nizam’s Institute of Medical Sciences |
Submittted/Under Review |
| TMC-ACTREC-IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Advanced Solid Malignancies, (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
NRC-2694-A |
NRC-2694-A is a small molecule tyrosine kinase inhibitor demonstrated anticancer activity in preclinical models of cancer
Starting dose og the study drug is 100 mg/day given orally for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Patients must be greater or equal to 18 years old with expected life expectancy more than 8 weeks.
•ECOG Performance Score less than or equal to 2
•Patients with evaluable disease, histologically documented confirmed diagnosis of an advanced solid malignancy for whom standard treatment options did not exist
•Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count greater than or equal to 2000/mm3, platelet count greater than or equal to 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level less than or equal to 2 times upper normal limit (UNL) and serum transaminases levels less than or equal to 2.5 times UNL/ less than or equal to 5 times for liver metastasis and/or obstructive jaundice. Subjects must have tested negative for, HIV, HbsAg and pregnancy (for female subjects)
•Patients must not have received chemotherapy within 14 days (6 weeks for nitrosureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing
•Patients must be willing to practice birth control during and for 2 months after treatment
|
|
| ExclusionCriteria |
| Details |
• Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy.
• Patients with brain metastases or primary CNS malignancies.
• Concurrent therapy for the cancer (Radiation therapy, chemotherapy etc)
• Patients who are pregnant or lactating.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug metabolism
• Impairment of gastrointestinal function that could significantly alter the absorption of the study drug and also the use of medication altering gastric pH (mild antacids are permitted if taken either 4 hours before or after the study drug administration)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse events at each dose level will be evaluated using clinical (physical examinations, ECGs and vital signs) and safety laboratory parameters namely Hematology (complete blood count, differential count, platelet count) and Biochemistry values. All adverse events will be graded using National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) |
Adverse events at each dose level will be evaluated using clinical (physical examinations, ECGs and vital signs) and safety laboratory parameters namely Hematology (complete blood count, differential count, platelet count) and Biochemistry values. All adverse events will be graded using National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic |
Day 1 and Day 12
|
| Tumor Evaluation |
Day 30, 60 and 90 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
13/01/2014 |
| Date of Study Completion (India) |
07/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Despite significant advances in systemic therapies, radiation oncology and surgical techniques, many patients with cancer are still incurable. One of the key approaches recently has been to target the receptor tyrosine kinases, which are often over expressed and/or mutated in many tumors and regulate proliferation, apoptosis, angiogenesis, tumor invasiveness and distant metastases. Though several agents have been developed in this area, there is a lot of scope for improvement in terms of newer and better agents.
Amplified epidermal growth factor receptor (EGFR) signaling is frequently found in human tumors and can be caused by various mechanisms. As amplified EGFR signaling plays an important role in carcinogenesis, inhibiting this process could be the rationale approach in the development of New Chemical Entity (NCE)
NRC-2694-A belongs to the quinazoline class of EGFR tyrosine kinase inhibitor demonstrated good anti cancer activity in preclinical studies. |