| CTRI Number |
CTRI/2009/091/000900 [Registered on: 19/11/2009] |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
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A clinical trial to study the effect of NRC-AN-019 in patients with various cancers. |
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Scientific Title of Study
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A Phase-I Clinical Study to Evaluate the Safety, Pharmacokinetics and Anti-Tumor Activity of NRC-AN-019 in Patients with Solid Tumors.
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NRCSOL019 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr D Raghunadharao |
| Designation |
Medical Oncologist |
| Affiliation |
Professor |
| Address |
Dept of Medical Oncology, Nizams Inst of Medical Sciences, Punjagutta
Dept of Medical Oncology, Nizams Inst of Medical Sciences, Punjagutta
Hyderabad
TELANGANA
500082
India |
| Phone |
040-23372947 |
| Fax |
040-66669049 |
| Email |
rdigumarti@gmail.com |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen C Myneni |
| Designation |
Medical Officer |
| Affiliation |
Sponsor |
| Address |
NATCO Pharma Ltd., NATCO House, Road No.2, Banjara Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
040-23547532 |
| Fax |
040-23545298 |
| Email |
pcmyneni@yahoo.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr G Venkat Ramana |
| Designation |
Clinical Research Scientist |
| Affiliation |
|
| Address |
NATCO Pharma Ltd., NATCO House, Road No.2, Banjara Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
040-23547532 |
| Fax |
040-23545298 |
| Email |
clinical@natcopharma.co.in |
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Source of Monetary or Material Support
Modification(s)
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| NATCO Pharma Ltd, Natco House, Banajara Hills Road No-2, Hyderabad |
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Primary Sponsor
Modification(s)
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| Name |
NATCO Pharma Ltd |
| Address |
Natco House, Road No-2, Banjara Hills, Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. R. Venkateswara Rao |
Krishna Institute of Medical Sciences |
Dept of Medical Oncology, Krishna Institute of Medical Sciences, Minister Road,-500003
|
09959789787
rkravi72@gmail.com |
| Dr. D. Raghunadharao |
Nizams Institute of Medical Sciences |
Dept of Medical Oncology, Nizams Institute of Medical Sciences, Punjagutta,-500082
Hyderabad
ANDHRA PRADESH |
040-23372947
040-66669049
draghu_hyd@dataone.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, Nizams Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patients of Non-Small Cell Lung cancer, Metastatic Breast Cancer, Pancreatic Cancer, Malignant Glioma, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
NRC-AN-019 |
200 mg Capsules for 30 days |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Patients must be greater than or equal 18 years old with expected life expectancy greater than 8 weeks.
2. Patients with disease not responding to currently available treatment options.
3. Patients must have recovered from the toxic effects of earlier radiotherapy or chemotherapy (if any)
4. Patients must have adequate bone marrow reserve
5. Patients must be willing to practice birth control during and for two months after treatment with study drug
6. Patients who are willing and able to give informed consent
7. Patients should have ECOG performance status less than or equal to 2.
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| ExclusionCriteria |
| Details |
1. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy.
2. Concurrent use of other chemotherapeutic agents
3. Pregnancy or lactation or non-practice of birth control during and for 2 months after treatment with study drug
4. 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.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| To estimate the Dose Limiting Toxicity and Maximum Tolerated Dose of NRC-AN-019 |
30 days |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| To characterize the Pharmacokinetics and therapeutic efficacy of NRC-AN-019 |
30 days |
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Target Sample Size
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Total Sample Size="72"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 1 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a multicentric open label Phase-I clinical study to evaluate the safety & efficacy of NRC-AN-019 in patients with Non-Small Cell Lung cancer or Metastatic Breast Cancer or Pancreatic Cancer or Malignant Glioma. NRC-AN-019 will be given as capsules of 200 mg in patients with any of the above indications enrolled at five centers in India. The primary outcome would be the estimation of dose limiting toxicity and maximum tolerated dose of the study drug. The secondary outcome would be the characterization of pharmacokinetics and efficacy of the study drug.
The stimated sample size of the study is 72 completed patients from five centers only in India. The study is anticipated to start enrollment by November 20, 2009. |