| CTRI Number |
CTRI/2014/10/005128 [Registered on: 22/10/2014] Trial Registered Prospectively |
| Last Modified On: |
09/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A multicenter, open label, balanced, randomized, two treatment, Two sequence, single dose, crossover biostudy in breast cancer patient. |
|
Scientific Title of Study
|
A MULTICENTER OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, SINGLE-DOSE, CROSSOVER BIOEQUIVALENCE STUDY OF PACLIALL(PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED BY PANACEA BIOTEC LTD., INDIA) WITH ABRAXANE® (PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED FOR CELGENE CORPORATION,USA) IN BREAST CANCER PATIENTS |
| Trial Acronym |
PacliAll |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/CR/2012/02/BE/PACLI Version 02 of 03-06-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Limited |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
South West
DELHI
110044
India |
| Phone |
911141679000 |
| Fax |
911141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Limited |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
DELHI
110044
India |
| Phone |
911141679000 |
| Fax |
911141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Limited |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
DELHI
110044
India |
| Phone |
911141679000 |
| Fax |
911141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Accutest Research laboratories |
Opp. The Grand Bhagwati,
S.G. Highway,
Bodakdev, Ahmedabad - 380 059,
Gujarat, India.
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mamraj Gupta |
Apex Hospital |
Department of Oncology ,Apex Hospital SP-4 & 6 ,Malviya Industrial Area, Malvia Nagar, Jaipur-302017 Rajasthan,India
Jaipur
RAJASTHAN |
09929685403
mamrajgupta@gmail.com |
| DrAjay Mehta |
Central India Cancer Research Institute |
Surgical Oncology,Central India Cancer Research Institute
11, Shankar Nagar,
West High Court Road,
Nagpur-440010
Nagpur
MAHARASHTRA |
09823190192
ajayonco@hotmail.com |
| DrNaresh Somani |
Somani Hospital |
Oncology Department, Somani Hospital, 277, Shri Gopal Nagar, 80 Ft. Road, Gopalpura Byepass, Jaipur – 302019 India
Jaipur
RAJASTHAN |
08104124996
drsomani@somanihealthcare.com |
| DrSPKataria |
Vardhman Mahavir Medical College & Sufdurjung Hospital |
VMMC & SAFDARJANG HOSPITAL
Ministry of Health & F.W., Govt. of India
NEW DELHI - 110 029
South
DELHI |
09868818541
spkataria@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central India Research Institute Ethics Committee |
Approved |
| Ethics Committee Apex Hospital Pvt Ltd |
Approved |
| Ethics Committee VMMC& Safdarjung Hospital |
Submittted/Under Review |
| Somex Research and Health Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abraxane® (Paclitaxel protein-bound particles for injectable suspension) |
Abraxane® (Paclitaxel protein-bound particles for injectable suspension)(albumin-bound) manufactured for Celgene Corporation, USA - 100 mg of paclitaxel in a single use vial
Patients will be randomized to receive 260 mg/m2 of Abraxane® (Paclitaxel protein bound particles for injectable suspension) intravenously as a 30-min infusion on cycle 1 day 1 followed 3 weeks later in cycle 2 day 1 by the alternate treatment.
|
| Intervention |
PacliALL (Paclitaxel protein-bound particles for injectable suspension) manufactured by Panacea Biotec Ltd., India |
PacliALL [Paclitaxel (protein-bound particles) for injectable suspension]
Each vial contains:
Paclitaxel IP 100 mg
Human Albumin IP q.s
Patients will be randomized to receive 260 mg/m2 of Paclitaxel protein bound particles for injectable suspension intravenously as a 30-min infusion on cycle 1 day 1 followed 3 weeks later in cycle 2 day 1 by the alternate treatment.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female, non-pregnant and non-lactating patients between 18 and 65 years of age (both inclusive). If patient is of child bearing potential, as evident by regular menstrual periods, she must have a negative serum pregnancy test at screening and negative urine pregnancy test on the day of admission of each period and if sexually active should agree to utilize contraception considered adequate and appropriate by the investigator.
2.Histologically or cytologically confirmed breast cancer
3.Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated
4.ER/PR –ve or ER/PR status unknown (defined as no histo-pathological evidence for confirmation of ER/PR status).
5.Patient has no other malignancy within the past 5 years except non-melanoma skin cancer, cervical intraepithelial neoplasia [CIN], or in situ cervical cancer [CIS].
6.Eastern Cooperative Oncology Group (ECOG)3 performance status of 0, 1 or 2 (refer annexure III)
7.Patiens who are suitable candidates for single agent paclitaxel treatment
8.Hematology levels at baseline of:
(i)ANC ≥ 1.5 × 109/L (1,500 cells/mm3)
(ii)Platelets ≥ 100 × 109/L (100,000 cells/mm3)
(iii)Hb ≥ 100 g/L (10 g/dL)
9.Adequate organ function at baseline as defined by:
(i)AST (SGOT), ALT (SGPT) ≤ 1.5 × upper limit of normal range (ULN)
(ii)Total bilirubin within normal range
(iii)Creatiine within normal range
(iv)Alkaline phosphatase ≤ 5  ULN
10.Expected survival of > 12 week
11.Patient is available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations.
12.Patient must have recovered from all toxicities of prior treatments to NCI-CTCAE v4.0 ≤Grade 1 before administration of study drug
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The 90% confidence interval for the Test/Reference (T/R) ratios of log transformed least square means of Cmax, AUC0→t and AUC0→∞ of total and free paclitaxel. |
Blood samples (6 ml each) for pharmacokinetic assessment will be collected at the following time points in Cycle/Period 1 and Cycle/Period 2: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 h after starting the infusion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative incidence and severity of clinical and laboratory adverse events (AEs). |
Comparative incidence and severity of clinical and laboratory adverse events (AEs). |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects with locally invasive or metastatic breast cancer will be enrolled after satisfying the inclusion/exclusion criteria.
Screening procedures will be performed within 8 days prior to administration of study medication. Spiral CT scan or MRI, if already undertaken within 28 days prior to administration of study medication shall be valid for the study and need not be repeated. (For details refer section 8).
Day 0 –The day of patient’s admission in cycles 1 and 2
Day 1-The day of administration of the IMP
Protocol treatment period is for 2 cycles. Patients will be randomized to receive 260 mg/m2 of Paclitaxel protein bound particles for injectable suspension of the test or reference product intravenously as a 30-min infusion on cycle 1 day 1 followed 3 weeks later in cycle 2 day 1 by the alternate treatment.
Subjects entering the trial would be admitted at least 12 h before administration of the study drug and would be discharged approximately 48h after dosing. Patients will be observed for longer period if clinically indicated and would be discharged only if found to be hemodynamically stable as judged by the investigator.
Subjects will visit the site for 72 h, 96 h and 120 h PK samples in both the cycles/periods.
|