| CTRI Number |
CTRI/2014/06/004689 [Registered on: 20/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
18/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) in patients with Ovarian Cancer |
|
Scientific Title of Study
|
A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) of LC-101, Lipocure Ltd (Investigational Product) and Lipodox (Doxorubicin Hydrochloride Liposome Injection), of Sun Pharmaceutical Industries Ltd. (Reference Drug), in patients with Ovarian Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LC-101-01 Version 1.0 dated 29/10/12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kasthuri P K |
| Designation |
Clinical Project Coordinator |
| Affiliation |
Quest Life Sciences Pvt. Limited |
| Address |
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Chennai
TAMIL NADU
600045
India |
| Phone |
|
| Fax |
|
| Email |
kasthuri@questlifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kasthuri P K |
| Designation |
Clinical Project Coordinator |
| Affiliation |
Quest Life Sciences Pvt. Limited |
| Address |
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Chennai
TAMIL NADU
600045
India |
| Phone |
|
| Fax |
|
| Email |
kasthuri@questlifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Kasthuri P K |
| Designation |
Clinical Project Coordinator |
| Affiliation |
Quest Life Sciences Pvt. Limited |
| Address |
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Quest Life Sciences Pvt. Limited,
SDF III, MEPZ, Tambaram, Chennai
Chennai
TAMIL NADU
600045
India |
| Phone |
|
| Fax |
|
| Email |
kasthuri@questlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Doxocure Ltd,
Hadassah Ein Kerem Campus,
Biotechnology Park,
POB 12133 Jerusalem, 91120, Israel |
|
|
Primary Sponsor
|
| Name |
Chaya Mazouz |
| Address |
Doxocure Ltd,
Hadassah Ein Kerem Campus, Minrav Building, Biotechnology Park POB 12235, Jerusalem 91120, Israel |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balashankar |
Axon Hospitals |
Clinical Research Division, 8-3-215, 3rd Floor, Srinivasa Nagar Colony (West), S.R. Nagar, Ameerpet Main Road, Opp. ICICI Bank
Hyderabad
ANDHRA PRADESH |
9440167173
sankarrmc2004@yahoo.co.in |
| Dr Velavan |
Erode Cancer Centre |
CR Division, 1st Floor, Velavan Nagar, Perundurai Road, Thindal, Erode
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr KNSrinivas |
G Viswanathan Speciality Hospitals |
27, Babu Road, 3rd Floor,
Tiruchirappalli
TAMIL NADU |
9443337230
kns68@yahoo.com |
| DrRamakrishna |
MNJ Institute of Oncology & Regional Cancer Centre |
GAIL Room, 3rd Floor, Red Hills, Lakdikapool
Hyderabad
ANDHRA PRADESH |
9849030979
rkmalladi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Axon Institutional Ethics Committee |
Approved |
| Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee Erode Cancer Centre |
Approved |
| MNJIO AND RCC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Ovarian Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LC-101 |
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, 2mg/mL (50mg/M2 DOSE), administered by Intravenous Infusion through an Infusion Pump. Frequency - Single, at-least 28 days between each drug administration. The total duration of the therapy will be for 28 days. |
| Comparator Agent |
LIPODOX |
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, 2mg/mL (50mg/M2 DOSE), administered by Intravenous Infusion through an Infusion Pump. Frequency - Single, at-least 28 days between each drug administration. The total duration of the therapy will be for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult female subjects between 18 to 75 years of age at the time of screening visit.
2. Availability of subject for the entire study period and willingness to adhere to protocol requirements.
3. Patients with documented diagnosis of Ovarian Cancer whose disease has progressed or recurred after platinum-based chemotherapy.
4. Subjects eligible for receiving a dose of 50mg/m2 of Doxorubicin liposome (preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
5. Patients with Performance ≤ 2 on the ECOG performance scale.
6. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
7. Signed written informed consent
|
|
| ExclusionCriteria |
| Details |
1. History or presence of significant:
a. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
b. Clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
c. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
d. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p. carinii or other microorganism
e. Clinically significant illness (except ovarian cancer)within four (4) weeks before the start of the study
f. Positive result to HIV.
g. Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
2. Subjects who have:
h. Systolic blood pressure less than 90 mmHg or more than 160 mmHg
i. Diastolic blood pressure less than 60 mmHg or more than 95 mmHg
j. Pulse rate below 60/min. or above 100/min
3. Subject under treatment of myelotoxic drugs
4. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s)
5. Subjects who are legally detained in an official institute
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of subjects participating in the study and to assess the bioequivalence of LC-101 in comparison to LipoDox®, in patients with ovarian cancer. |
Predose 5 ml each
0.00
0.25
0.50
0.75
1.00
1.083
1.250
1.50
2.00
4.00
6.00
9.00
25.00
49.00
97.00
169.00
241.00
337.00
504.00
672.00 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Primary Analytes following 28 Days post treatment
Free doxorubicin
Liposome encapsulated doxorubicin
Secondary Analytes following 28 Days post treatment
Doxorubicinol, a metabolite of doxorubicin
All samples will be measured in plasma using validated LC/MS/MS methods
|
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2013 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a randomized, multi center, open label,
two treatments, two periods, two sequences, single dose, crossover,
bioequivalence study of Doxorubicin Hydrochloride Liposome injection, 2 mg/mL
(50 mg/m2 dose). Subjects will be
treated first with a single dose of the RLD (approved liposomal Doxorubicin
Hydrochloride) or suggested generic formulation. Following 30+2 days
after first treatment the same subject will be treated with the suggested
generic formulation or RLD, respectively.
The study will comprise:
1.
Screening
period of up to 30 days
2.
First
treatment with RLD or generic formulation
3.
PK
Blood sampling through Day 28
4.
Second
treatment with RLD or generic formulation on Day 30+2 days
5. PK
Blood sampling through Day 56 and termination visit (28 days post second
treatment)
A sufficient number of patients with ovarian
cancer shall be recruited in order to complete the study with at least 24 patients. |