A Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial in Patients with Metastatic Breast Cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/12/048030
- Lead Sponsor
- Alembic Pharmaceuticals Limited,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
. Female patient 18 to 70 years of age (both inclusive)
2. Patient with life expectancy of at least 6 months at the time
of enrollment.
3. Patient having breast cancer
a) after failure of combination chemotherapy for metastatic
disease or
b) relapse within 6 months of adjuvant chemotherapy
c) has histological or cytological confirmed breast cancer who
is a candidate for albumin bound Paclitaxel therapy in
accordance with the standard of care as per PI judgement in
discussion with the Medical Monitor (NCCN 2021).
d) and prior therapy should have included an anthracycline
unless clinically contraindicated
4. Body surface area (BSA) that is within 1.2 to 2.2 m2,
calculated using the DuBois Formula (Appendix V).
5. Eastern Cooperative Oncology Group (ECOG) performance
status = 2 as per Appendix II
6. Hematology/chemistry: Patient has adequate hematological,
renal, and hepatic function as defined by the following
screening laboratory values obtained within 21 days prior to
randomization (patients should not have received a
transfusion within 7 days before the screening laboratory
assessments):
a) Absolute neutrophil count (ANC) = 1,500 cells/mm3 (1.5
x 109/L)
b) Platelet count = 100,000 cells/mm3 (100 x 109/L)
c) Hemoglobin = 9 g/dL
d) Serum creatinine = 1.5 x the upper limit of normal (ULN)
e) Total bilirubin = 1.5 x ULN
f) AST (SGOT) = 2.5 x ULN (= 5 x ULN in case of liver
metastasis)
g) ALT (SGPT) = 2.5 x ULN (= 5 x ULN in case of liver
metastasis)
7. All other clinical laboratory values deemed normal or not
clinically significant judged by the Investigator.
8. Female with postmenopausal status or female of childbearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout
the study period and for at least 6 months after last dose of
study drug.
9. Able and willing to adhere to all protocol requirements and
study procedures throughout the study
1. Patient with a history of other malignancies, except for
adequately treated non-melanoma skin cancer, curatively
treated in situ carcinoma of the cervix, in situ carcinoma of
the breast or other solid tumors with no evidence of
recurrence for = 5 years.
2. Patient who has previously received a taxane within 30 days
prior to randomization.
3. Patient who has not completely recovered from any
toxicities from previous chemotherapy, hormone therapy,
immunotherapy, or radiotherapies Grade 1 or higher by
(National Cancer Institute-Common terminology criteria for
Adverse Events) NCI-CTCAE, with the exception of
alopecia.
4. Prior chemotherapy must be completed at least 30 days prior
to randomization (42 days for mitomycin C or nitrosoureas).
Prior immunotherapy, prior antitumor hormonal therapy, and
prior radiotherapy must be completed at least 14 days prior
to randomization.
5. Patient had major surgery within 30 days prior to
randomization, or Patient has not recovered from prior major
surgery.
6. Sensory / Peripheral neuropathy of Grade 2 or higher by
NCI-CTCAE Version 5.0 or higher at Screening.
7. Abnormal ECG: QTc >470 msec in female patient at
screening and randomization [QTc interval will be calculated
with Bazett’s Formula] (Refer Appendix IV)
8. Patient with known brain metastases, with the exception of
patient who has completed surgery and/or radiotherapy at
least 30 days prior to randomization, has completed any
steroids as treatment for the metastases at least 30 days prior
to randomization, and who is currently asymptomatic.
9. Known history or presence of any clinically significant
disease or condition other than cancer unless determined as
not clinically significant by the Investigator.
10. History of difficulty with vascular access.
11. Known history or presence of:
a) Human Immunodeficiency Virus (HIV), Hepatitis B, or
Hepatitis C
b) Alcohol or drug abuse or dependence within one year
prior to randomization
c) Hypersensitivity or idiosyncratic reaction to Paclitaxel,
its excipients, and/or related substances, including,
albumin and PEG.
12. Patient may not participate in any other clinical
investigational trial that involves administration of
experimental therapy and/or the use of investigational
devices with therapeutic intent within 30 days prior to
randomization and while enrolled in this study.
13. Pregnant, lactating or breastfeeding female
14. Use of any strong inhibitor or inducer of CYP2C8 and
CYP3A4 in the previous 14 days before randomization.
15. Acute active infection requiring treatment within 14 days
prior to randomization.
16. Any other condition that, in the Investigator’s judgement,
might increase the risk to the patient or decrease the chance
of obtaining satisfactory data needed to achieve the
objectives of the study
17. Patient has consumed any xanthine containing food or
beverages (tea, coffee, chocolates or cola drinks), tobacco,
tobacco containing products (like pan, pan masala, gutkha),
beedi, cigarette within 24 hours prior to each IP administration.
18. Patient has consumed gra
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A study to evaluate the bioequivalence of Paclitaxel Protein bound <br/ ><br>Particles for Injectable Suspension (albumin-bound), <br/ ><br>100 mg/vial of Alembic Pharmaceuticals Ltd, India with <br/ ><br>Abraxane 5 mg/ml powder for dispersion for infusion of <br/ ><br>Bristol-Myers Squibb Pharma EEIG, Ireland in Patients with <br/ ><br>Metastatic Breast Cancer under standard diet (non-high-fat) <br/ ><br>conditions <br/ ><br>Timepoint: 96 hours
- Secondary Outcome Measures
Name Time Method To evaluate the safety of study products.Timepoint: 96 hours