FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/079937 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   An open label, multicenter, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, pharmacokinetic, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial in metastatic breast cancer patients. 
Scientific Title of Study   A multicenter, open label, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial of Hetero Labs Limited, India with ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation Summit, NJ 07901 in metastatic breast cancer patients. 
Trial Acronym  PAC 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. PAC-077-24, Version No.: 01, Date: 17 Sep 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raju Lingumpelly 
Designation  Assistant General Manager 
Affiliation  Clians Labs Private Limited  
Address  Clians Labs Private Limited 3rd and 4th Floor, Plot no. 38/A, Vibrant Center, IDA-Balanagar, Hyderabad-500 037, Telangana, India.

Hyderabad
TELANGANA
500037
India 
Phone  9100065465  
Fax    
Email  Drraju.L@clianslabs.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raju Lingumpelly 
Designation  Assistant General Manager 
Affiliation  Clians Labs Private Limited  
Address  Clians Labs Private Limited 3rd and 4th Floor, Plot no. 38/A, Vibrant Center, IDA-Balanagar, Hyderabad-500 037, Telangana, India.

Hyderabad
TELANGANA
500037
India 
Phone  9100065465  
Fax    
Email  Drraju.L@clianslabs.com  
 
Details of Contact Person
Public Query  
Name  Dr Raju Lingumpelly 
Designation  Assistant General Manager 
Affiliation  Clians Labs Private Limited  
Address  Clians Labs Private Limited 3rd and 4th Floor, Plot no. 38/A, Vibrant Center, IDA-Balanagar, Hyderabad-500 037, Telangana, India.

Hyderabad
TELANGANA
500037
India 
Phone  9100065465  
Fax    
Email  Drraju.L@clianslabs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited,7-2-A2, Hetero Corporate,Industrial Estates, Sanathnagar, Hyderabad–500018 Telangana, India.  
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanathnagar, Hyderabad–500018 Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clians Labs Private Limited   Clians Labs Private Limited 4th Floor, Plot no. 38/A, Vibrant Center, IDA-Balanagar, Hyderabad-500 037, Telangana, India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venugopal Arroju  Indur Cancer Hospital  Indur cancer hospital, Madhavanagar, Pangra, Nizamabad,Telangana-503001.
Nizamabad
TELANGANA 		 9980707675

Venugopal.arroju@picancerhospital.ai 
Dr Pradeep Kumar Reddy K  Mahabubnagar Cancer Hospital  Mahabubnagar Cancer Hospital 2nd &3rd floor, Arogya complex, opp. Citi endoscan, Rajendra Nagar, Mahbubnagar, Telangana 509001.
Mahbubnagar
TELANGANA 		 99902280779

Kpkreddy.medonco@gmail.com 
Dr SrikanthR  MNJ Institute of oncology and regional cancer centre  MNJ Institute of oncology and regional cancer center, red hills, 3rd floor, Lakadikapul, Hyderabad-500004, Telangana.
Hyderabad
TELANGANA 		 9849009958

srikanthsapthagiri@yahoo.com 
DR JAIN MINISH MAHENDRA  Prolife Cancer Centre and Research institute  Prolife Cancer Centre,557A1, 15C, Jawaharlal Nehru Rd, Burhanj Baug-B Colony, Market Yard, Gultekadi, Pune, Maharashtra 411037
Pune
MAHARASHTRA 		 9823133390

dr.minishjainmhtrials@gmail.com 
Dr Radheshyam  Sammprada Hospital  Sammprada cancer Hospital No 76-1-1, Sarakki Main Rd, VR Layout, 1st Phase, J. P. Nagar, Bengaluru, Karnataka 560078.
Bangalore
KARNATAKA 		 9731310682

Radheshyam_n@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
IEC Dr Dada Gujar Hospital for Mother and Child  Approved 
IEC-SAMMPRADA MEDICARE PRIVATE LIMITED  Not Applicable 
Indur Cancer Hospital Ethics Committee  Not Applicable 
Mahabubnagar Cancer Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ABRAXANE®  260 mg/m², intravenous infusion, Administration of the Investigational product will be done on Day 1 of 21-day cycle.  
Intervention  Paclitaxel protein-bound particles for injectable suspension (albumin-bound)   260 mg/m², intravenous infusion, Administration of the Investigational product will be done on Day 1 of 21-day cycle. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.Female patients, 18 to 65 years of age (both inclusive) at the time of screening and capable of giving written informed consent prior to receiving any study medication.

2.Meets one of the following criteria: a)Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease. OR b)Has had a relapse within 6 months of adjuvant chemotherapy. OR c)Has histological or cytological confirmed breast cancer who is a candidate for albumin bound paclitaxel therapy in accordance with the standard of care (NCCN guidelines- Breast Cancer) as per PI judgement. Note: In the case of items a and b above, prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds unless clinically contraindicated.

3.Patients with life expectancy of at least 6 months as per the investigators opinion.

4.ECOG performance status of less than or equal 2.

5.Acceptable hemopoietic, renal and liver function( Bone marrow function: ANC greater than or equal 1500 cells per mm3 or 1500 cells per microliter, Platelet count greater than or equal 100,000per mm3, Hemoglobin greater than or equal 9.0g per dl. Renal function: Serum Creatinine less than 1.5 times ULN, Hepatic function: AST and ALT less than 2.5 times ULN (less than 4 X ULN for liver metastasis), Alkaline phosphatase less than2 times ULN (5 X ULN for bone metastasis), Bilirubin less than 1.5 times ULN)

6.All other clinical laboratory values deemed as not clinically significant by the principal investigator/sub-investigator.

7.Availability for the entire study duration and willingness to comply/adhere to the protocol requirements.

8.Female patients must fulfil at least one of the following: Be surgically sterile for a minimum of 6 months, Post-menopausal for a minimum of 1 year of study consent date; Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to dosing and until 6 months after the study has ended (last study procedure). Medically acceptable methods of contraception include nonhormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.  
 
ExclusionCriteria 
Details  1.History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin bound) or any related compound at any dose.

2.History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.

3.Sensory peripheral neuropathy of greater than Grade 2 at baseline.

4.Presence of any significant physical or organ abnormality or active opportunistic infection (mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator.

5.Patients not completely recovered from any toxicities from previous chemo, hormone, immuno, or radiotherapies Grade 1.

6.Patients who are, Pregnant or breast feeding, pr of childbearing potential without a negative pregnancy test at baseline had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.

7.Known history or presence of Alcohol abuse or dependence within one year prior to first drug administration or Drug abuse or dependence or severe allergic reactions (e.g. anaphylactic reactions, angioedema) or History of difficulty with donating blood or difficulty in accessibility of veins.

8.Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X ray findings, as judged by investigator.

9.Any other condition, that in the investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

10.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.

11.Any chemotherapy, targeted therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrolment (6 weeks for mitomycin C or nitrosurea). Additional requirements include, Immune therapy or hormonal therapy (except palliative bisphosphonate therapy for bone pain) must be completed 2 weeks before enrolment, patients must have recovered from all toxicities resulting from previous therapy, except for alopecia, Use of targeted therapy or antibody therapy should have been completed for at least 5 half lives of the respective therapy before enrolment, Narcotic analgesics, such as dihydrocodeine, must have been discontinued at least 2 weeks before enrolment, Medicinal herbs, such as St. Johns Wort (which may act as inhibitors or inducers of CYP2C8 and CYP3A4), must have been discontinued at least 4 weeks before enrolment.

12.Presence of pleural or ascitic fluid which cannot be definitively treated prior to dosing and during the PK blood draws in each period (Period 1 and Period 2) and if there is re accumulation of fluid (greater than 5 percent ) greater than 2 weeks after definitive management.

13.Positive laboratory exclusion test (HIV, HBsAg, or HCV)

14.Treatment with investigational agents or participation in a clinical trial within 30 days of study entry.

15.Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit

16.Serious non-healing wound, ulcer or bone fracture

17.History of gastrointestinal perforation within 6 months prior to screening visit.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To characterize the pharmacokinetic profiles of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial (test product) to ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial (reference product) in breast cancer patients.  Pharmacokinetic blood sample time points will be collected at 0.00 and 0.16, 0.33, 0.50, 0.66, 0.83, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 20.00, 24.00, 36.00, 48.00, 72.00, and 96.00 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the safety & tolerability  At baseline, 3 weeks & 6 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/10/2025 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is a multicenter, open label, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, bioequivalence study in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Treatments will be allocated to the patients as per the SAS generated randomization sequence (i.e. T-R or R-T). The Test (T) or Reference (R) products will be administered as a 30-minute (±2minutes window period) intravenous infusion on Day 1 of each treatment period per two Consecutive Cycles (i.e., Administration of the Investigational products will be done on Day 1 of each 21-day cycle).

During each treatment period, serial blood samples will be collected at pre-determined time-points. Patients will remain in the clinical research until 96 hours post-dose. Pharmacokinetic samples will be collected up to 96 hours after the start of the infusion. Sensory peripheral neuropathy as per the standard practice at each study visit. Plasma concentration of drug i.e. unbound and total paclitaxel will be quantified by using validated analytical method. Statistical analysis of pharmacokinetic parameters of test and reference formulations will be performed to assess bioequivalence.

 
Close