| CTRI Number |
CTRI/2014/11/005204 [Registered on: 14/11/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Nanosomal Docetaxel Lipid Suspension for Injection in Locally Advanced or Metastatic Breast Cancer Patients. |
|
Scientific Title of Study
|
An Open Label, Parallel, Randomized Study to Evaluate the pharmacokinetics, Safety and Efficacy at three doses of Nanosomal Docetaxel Lipid Suspension for Injection in Locally Advanced or Metastatic Breast Cancer Patients after failure of prior chemotherapy. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 740-14; Version 01; 17 Sep 14 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Amol Dongre |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court, S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202562 |
| Fax |
07940202021 |
| Email |
amoldongre@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court, S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd Floor, Chinubhai Centre,
Ashram Road, Ahmedabad-380 009. Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeti Sharma |
Acharya Tulsi Regional Cancer Treatment & Research Institute |
Department of Radiotherapy,S. P. Medical College & AG of Hospitals-334003
Bikaner
RAJASTHAN |
9461159531
drneetisharma@rediffmail.com |
| Dr Patel Ghanshyam Nanubhai |
Apple Hospital |
Udhna Darwaja ,Ring Road-395002
Surat
GUJARAT |
9376913131
gnonco@gmail.com |
| Dr S Malik |
BIBI General Hospital & Cancer Centre |
16-3-991/1/C, Government Printing Press Road Malakpet-500024
Hyderabad
ANDHRA PRADESH |
9866008946
drmalik.onco@gmail.com |
| Dr Smita Gupte |
Cancer Clinic & Nursing Home |
Block 4B, Hyatt Medicare, Plot No. 12/2, Dr. N. B. Khare Marg, Dhantoli-440012
Nagpur
MAHARASHTRA |
9373107176
cancerclinic9@gmail.com |
| Dr Mamillaplli Gopichand |
City Cancer Centre |
City Cancer Centre, 33-25-33, Ch. Venkata Krishnayya Street, Suryaro Pet, Vijaywada-520002, Andhra Pradesh, India
Krishna
ANDHRA PRADESH |
988526059
mgopichand@yahoo.com |
| Dr Rajnish Vasant Nagarkar |
Curie Manavata Cancer Centre |
Opp. Mahamarg Bus Stand, Mumbai Naka-422004
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Kadappan Velavan |
Erode Cancer centre |
1/393, Erode Cancer centre, velavan nagar, near chinthormani petrol bunk, Periundwai Road,Thindal
Erode
TAMIL NADU |
9842922443
kvels@rediffmail.com |
| Dr Vijay Mahobia |
Government Medical College and hospital |
Department of Oncology and Radiology, Govt Medical College and hospital, Medical College Square-440003
Nagpur
MAHARASHTRA |
9881287465
drvijay-mahobia@yahoo.com |
| Dr Sameer Gupta |
King Geroges Medical University |
Department of Surgical Oncology, Chowk,Shah Mina Road-226003
Lucknow
UTTAR PRADESH |
9235042555
sameerdr79@gmail.com |
| Dr Krishnakumar Rathnam |
Meenakshi Mission Hospital and Research Centre |
Department of Oncology, Lake Area, Melur Road-625107
Madurai
TAMIL NADU |
9380417299
kkrathnam@gmail.com |
| Dr Mukesh S |
MMC & RI, K.R.Hospital |
Dept of Radiation Oncology, K R Hospital, Mysore Medical College & Research Institute-570001
Mysore
KARNATAKA |
9886873788
dal_muk1@hotmail.com |
| Dr Ajay Khatri |
Samvedna Hospital |
B27/889,Ravindrapuri-221005
Varanasi
UTTAR PRADESH |
9918429594
drajay291991@gmail.com |
| Dr Tamohan Chaudhuri |
Saroj Gupta Cancer Centre & Research Institute |
Mahatma Gandhi Rd, Thakurpukur Cancer Hospital, Thakurpukur-700104
Kolkata
WEST BENGAL |
9830035796
researchccwhri@gmail.com |
| Dr Rudhresh A H |
Srinivasam Cancer Care Hospital India Pvt Ltd |
Department of Radiology,No. 236/1, vijayashree layout, Arekere, Bannerghatta Main Road- 560076
Bangalore
KARNATAKA |
9480369521
rudresha.ah@gmail.com |
| Dr Jitendra Kumar Singh |
SS Hospital & Research Centre |
Doctors Colony, Malahi Pakri Chowk, Kankarbagh-800020
Patna
BIHAR |
9431021001
drjksingh147@hotmail.com |
| Dr Hitendra B Ayre |
Unique Hospital Multispeciality & Research Institute |
Opp Kiran Motor, Nr. Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off Ring Road-395002
Surat
GUJARAT |
9227230347
hitendra_ayre@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Apple Hospital Ethics Committee, Apple Hospital |
Approved |
| BIBI Institutional Ethics Committee,BIBI General Hospital & Cancer Centre |
Approved |
| Ethics Committee Unique Hospital Multispeciality & Research Institute |
Approved |
| Ethics Committee, S. P. Medical College & AG of Hospitals,Dr. Neeti Sharma |
Approved |
| Ethics Committee, Samvedna Hospital |
Approved |
| Institutional Ethics Committee, City Cancer Centre |
Approved |
| Institutional Ethics Committee, Erode Cancer Centre |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
| Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, SS Hospital & Research Centre |
Approved |
| Institutional Ethics Committee,Dr. Mukesh S |
Approved |
| Institutional Ethics Committee,Government Medical College and hospital |
Approved |
| Institutional Ethics Committee,Saroj Gupta Cancer Centre & Research Institute |
Approved |
| Jasleen Hospitals Ethics Committee,Cancer Clinic & Nursing Home |
Approved |
| Manavata Clinical Research Institute Ethics Committee,Curie Manavata Cancer Centre |
Approved |
| Srinivasam Cancer Care Hospitals - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NDLS_Intas |
Dose: 60, 75 and 100 mg/m2, Mode of Administration: IV, Duration of treatment and frequency:6 cycles (21 days per cycle) |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.The patient willing to give written signed and dated informed consent to participate in the study.
2.Female ≥18 years and ≤65 years of age.
3.Patient must have histopathologically /cytologically confirmed breast cancer.
4.Patient must have locally advanced or metastatic breast cancer after failure of chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated
5.Have at least one measurable lesion as per the RECIST criteria (version 1.1).
6.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
7.Left Ventricular Ejection fraction (LVEF) ≥ 50% as per Echocardiography (ECHO).
8.Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
9.Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration.
10.Patients with life expectancy of at least 6 months.
11. Serum pregnancy test at screening and urine pregnancy test on Day 1(before randomization) must be negative.
12.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. (It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).
13.Patient with adequate bone marrow, renal and hepatic function. |
|
| ExclusionCriteria |
| Details |
1.Patient who has a history of hypersensitivity reactions to docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
2.Patients with HER2+ status
3.Patient who is already exposed to docetaxel injection.
4.Any of the following cardiac conditions:
a.Unstable angina
b.Myocardial infarction within the past 6
months
c.Severe uncontrolled ventricular arrhythmias
d.Clinically significant pericardial disease
e.Electrocardiographic evidence of acute
ischemia
f.Patient with evidence of abnormal cardiac
conduction (e.g., bundle branch block or
heart block) except in whom the disease
has been stable for the past six months
g.History of cardiac disease that met the
NYHA Classification class 2 or greater.
5.Uncontrolled diabetes or infection.
6.Known history of drug addiction within last 1 year.
7.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
8.The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.
9.Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE 4.03 criteria.
10.Known case of HIV infection.
11.Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
12.Patients who are unwilling or unable to follow protocol requirements.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare safety, pharmacokinetics (PK) of NDLS at three dose levels in locally advanced or metastatic breast cancer patients. |
6 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To compare the BOR (CR or PR) to evaluate the efficacy of NDLS |
6 cycles |
| • To evaluate the exploratory exposure-response relationship for NDLS in patients for efficacy and toxicity in locally advanced or metastatic breast cancer |
6 cycles |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/11/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An Open Label,
parallel, randomized Study to Evaluate the Pharmacokinetics, Safety and
Efficacy at three doses of Nanosomal Docetaxel Lipid Suspension for Injection
in Locally Advanced or Metastatic Breast Cancer Patients after failure of prior
chemotherapy.
Drug will be
administered by IV infusion over 1 hour at a dose of 60, 75 and 100 mg/m2.
Patients will be treated every 21 days (a treatment cycle) in the absence of
disease progression or unacceptable toxicity. Disease status and tumor response
will be assessed after every 3 cycles of treatment using Response Evaluation
Criteria in Solid Tumors (RECIST version 1.1) guidelines through cycle 6
(including confirmation of response if required); subsequent cycles will follow
institutional standards for tumor/disease assessment.
The proposed study will
evaluate the safety, efficacy and exposure response relationship at three dose
level for Nanosomal Docetaxel Lipid Suspension (NDLS) in breast cancer
Patients. Based on the goals of therapy and the individual characteristics of
the patient, each of the doses being studied in this trial may be appropriate,
with lower doses having potential utility in patients who are frail or have
specific tolerability concerns. |