CTRI/2025/10/096192 [Registered on: 17/10/2025] Trial Registered Prospectively
Last Modified On:
21/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
This is a study to evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid Suspension Compared with Weekly Conventional Paclitaxel in the Patients.
Scientific Title of Study
A Phase-3, Randomized, Parallel Group, Open-label, Multicenter, Two-Arm
Treatment Study to Evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid
Suspension Compared with Weekly Conventional Paclitaxel in the Patients with
Platinum-Resistant/Refractory Recurrent High-grade Serous Epithelial Ovarian
Cancer Including Fallopian Tube and/or Primary Peritoneal Cancer
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol Number : 0127-23, Version: 6.0, Dated : 19-Oct-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Naman Shah
Designation
Senior General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak
Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak
Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak
Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India
GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Jina Pharmaceuticals Inc.
28100 Ashley Circle, Ste 103 Libertyville, IL 60048
Primary Sponsor
Name
Jina Pharmaceuticals Inc
Address
28100 Ashley Circle, Ste 103 Libertyville, IL 60048
Department of Clinical
research, Room No.
NA, 1/393 Velavan Nagar, Perundurai Road, Thindal, Erode- 638012 Tamil Nadu, INDIA
Erode TAMIL NADU
7200060276
Drkharthik.research@gmail.com
Dr Rajeev Sood
Guru Gobind singh Medical college & Hospital
Department of Clinical research, Room No. NA, 1st floor Urology ward, Guru Gobind Singh Medical College & Hospital , Sadiq Road, Faridkot - 151203 Punjab , India
Faridkot PUNJAB
9810005182
drsoodr@gmail.com
Dr Vijay Bhargava
Jawaharlal Nehru Cancer Hospital
Department of Clinical research, Room No. NA, Jawaharlal Nehru Cancer Hospital and Research Centre Idgah Hills Bhopal, Madhya Pradesh - 462001 India
Bhopal MADHYA PRADESH
MNJ Institute of oncology and Regional Cancer Center
Department of Clinical research, Room No. NA, MNJ Institute of oncology and Regional Cancer Center Red Mills, 3rd Floor, Clinical Trail, Hyderabad, Telangana- 500004
Hyderabad TELANGANA
9848792682
radhika.parimkayala@gmail.com
Dr Bhushan Nemade
Sankalp Speciality Hospital
Department of Clinical research, Room No. NA, Dhanvantari Marg, Vallabh Nagar, Behind Chhan Hotel, Mumbai Agra Highway, Mumbai Naka, Nashik- 422009, Maharashtra, India
Nashik MAHARASHTRA
9766126162
drbtnemade@yahoo.co.in
Dr Vinayak Munirathnam
Shri Shankara Cancer Hospital & Research Centre
Department of Clinical research, Room No. NA, 1st cross, Shankrampuram, Shankara Math premisses, Basavanagudi, Benguluru- 560004 , Karnataka
Bangalore KARNATAKA
9544593491
munirathnamvinayak@gmail.com
Dr Rajender Singh Arora
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Department of Clinical research, Room No. NA, Sujan Surgical Cancer Hospital, Jewad Nagar Chatri Talao Road, Amravati-444601 Amravati MAHARASHTRA
9823097573
rsaroradr@gmail.com
Dr Kajal Shah
The Guj arat Cancer & Research Institute
Department of Clinical research, Room No. NA, M.P. Shah Cancer Hospital, Civii Hospital Campus, Asarwa, Ahmedabad-3 800 1 6, Guiarat. India Ahmadabad GUJARAT
Amravati Ethics Committee, Dr. Rajender Singh Arora
Approved
GCRI GCS Ethics Committee, Dr. Kajal Shah
Approved
Institutioanal Ethics Committee of Jawaharlal Nehru Cancer Hospital and Research Centre, Dr. Vijay Bhargava
Approved
Institutional Ethics Committee, Dr. Rajeev Sood
Approved
Institutional Ethics Committee- Erode Cancer Centre, Dr. Kharthik Nattramil Arasu
Approved
MNJ Institute of Oncology and Regional Cancer Center Ethics Committee, Dr. Parimkayala Radhika
Approved
Navsanjeevani Hospital Ethics Committee, Dr. Bhushan Nemade
Submittted/Under Review
Ranchi Urology Centre Institutional Ethics Committee Ranchi urology center, Dr. Kumar Saurabh
Approved
Sri Shankara Cancer Hospital and Research Centre, Dr. Vinayak Munirathnam
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Conventional Paclitaxel Injection-R
Dose: 80 mg/m2 weekly regimen (Dosing on Day 1, Day 8 and Day 15 of each 28 days cycle)
Intervention
Paclitaxel Lipid Suspension for Injection (1 mg/mL)-T
Each vial contains lyophilized Paclitaxel lipid
powder, equivalent to 60 mg or 100 mg of anhydrous Paclitaxel
Dose: 80 mg/m2 weekly regimen (Dosing on Day 1, Day 8 and Day 15 of each 28 days cycle)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Female
Details
1) The participant is willing to give written signed and dated informed consent to participate in the study.
2) Female greater than or equal to 18 years of age fulfilling all other eligibility criteria.
3) Participants must have histopathologically cytologically confirmed diagnosis of high-grade serous epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal carcinoma. Non-epithelial or mixed (less than 50 percentge of the primary tumor confirmed to be high-grade serous) epithelial non-epithelial tumors (including malignant mixed Müllerian tumors), ovarian tumors with low malignant potential (borderline tumors), endometrioid, clear cell, mucinous or low-grade serous carcinomas or not otherwise specified (NOS) ovarian tumors are excluded. Refer to Appendix 8 for criteria defining high-grade serous ovarian carcinoma.
4) Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Platinum-resistant refractory disease is defined as disease progression within 6 months (182 days) following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively for whom single-agent paclitaxel is considered an acceptable therapeutic option by the investigator. Note: Progression due to rising CA125 only is not considered a platinum-resistant disease. Disease progression may be either radiographic progression or documented clinical progression. The residual disease is not considered progression. Progression on a nonplatinum- containing regimen is eligible if the participant is considered platinum-resistant to the last platinum-containing regimen.
5) Participants must have received at least one-prior platinum-based chemotherapy regimen, including cisplatin, carboplatin or other organoplatinum compounds, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer.
6) Have at least one measurable lesion as per the RECIST criteria (version 1.1).
7) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
8) Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO).
9) Participant has recovered from adverse events (baseline or less than or equal to CTCAE Grade 1) due to prior anti-cancer therapy(ies) (including surgery, radiotherapy, chemotherapy, targeted therapy, hormonal therapy) unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator.
10) Participants with life expectancy of at least 6 months in the Investigators opinion.
11) A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 5: Contraception and Barrier Guidance. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in section Appendix 5: Contraception and Barrier Guidance during the intervention period and for at least 6 months after the last dose of IMP. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the
contraceptive method in relationship to the first dose of IMP. A WOCBP agrees not to donate eggs (ova, oocytes) or freeze them for future use for reproduction during the recommended period of contraception. A WOCBP agrees to seek advice about the donation and cryopreservation of germ cells. A WOCBP must have a negative highly sensitive serum pregnancy test at screening and
a negative urine pregnancy test within 24 hours before the first dose of IMP. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after IMP are located in section 7.10. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
12) Participants with adequate bone marrow, renal and hepatic function as defined below:
a) ANC greater than or equal to 1500 per mm3 without granulocyte colony-stimulating factor support within 1 week before the screening assessment.
b) Platelet counts greater than or equal to 100,000 per mm3 without any platelet transfusion per platelet concentrate within 1 week before the screening assessment.
c) Hemoglobin greater than or equal to 9 gm per dL. Criteria must be met without packed red blood cells (pRBC) or whole blood transfusion within 1 week before the screening assessment.
d) Creatinine clearance greater than or equal to 30 mL per min as calculated using the Cockcroft-Gault equation
e) Total bilirubin less than or equal to ULN
f) ALT per AST less than or equal to 1.5 times ULN (less than or equal to 5.0 into ULN if liver metastases are present)
g) Alkaline phosphatase less than or equal to 2.5 times ULN (less than or equal to 5.0 into ULN if liver metastases are present)
13) Has had prior PARP inhibitors for participants with documented breast cancer gene (BRCA) mutation (germline and or somatic) or HRD status, unless the participant is not eligible for treatment with a PARP inhibitor due to precautions intolerance, or if the treatment is not
approved locally or not available due to any reasons.
Note: BRCA and or HRD status will be based on history of documented testing and participants will not be screened for BRCA and or HRD testing for the current study. Participant without known BRCA HRD status will be considered as negative benign.
14) Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions intolerance, or if the treatment is not approved
or available locally. Note: Folate receptor alpha expression will be based on history of documented testing and
participants will not be screened for folate receptor alpha expression testing for the current study. Participant without known expression status will be considered as negative for Folate receptor alpha expression.
15) Participants must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study
ExclusionCriteria
Details
1) Have previously received paclitaxel at any time in the platinum-resistant setting. This does not apply to the participants who have received paclitaxel either in a neo adjuvant setting in the first line or platinum-sensitive relapse.
2) Participants who are candidates for debulking surgery, or in whom chemotherapy is planned to shrink the otherwise inoperable tumor and make it operable even if the intent is palliative.
3) Participants who are planned to receive concurrent PARP inhibitors based on BRCA positivity and HRD status in line with approved indications of respective PARP inhibitors.
4) Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers. Refer Appendix 2 for detailed list of Inhibitors and Inducers.
5) Participants who are planned for concurrent bevacizumab along with IMP for their disease management during the study. Participants who have received bevacizumab in the past for
the management of ovarian cancer are eligible. Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently).
6) Participants with clinically significant current or recent (within the past 6 months before
randomization) cardiac conditions as defined below: Unstable angina, Myocardial infarction, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemia, Participants with evidence of abnormal cardiac conduction (e.g., bundle branch block or
heart block) except in whom the disease has been stable, History of cardiac disease that met the NYHA Classification class 2 or greater, Cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
7) Uncontrolled diabetes (defined as HbA1c greater than or equal to 8 percentage as per ADA) or has an active infection requiring systemic therapy.
8) History of drug or alcohol abuse according to medical history assessment by the investigator
within 1 year before Screening or positive test result for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at Screening.
9) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided
they are stable (without evidence of progression by imaging for at least four weeks before the
first dose of trial treatment and any neurologic symptoms have returned to baseline), have no
evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days
before trial treatment. This exception does not include carcinomatous meningitis which is
excluded regardless of clinical stability.
10) The receipt of an investigational medicinal product or participation in other drug research
study within a period of 30 days before the first dose of an investigational medicinal product
for the current study.
11) Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 as defined by NCI CTCAE v5.0 criteria.
12) History of clinically significant liver or renal insufficiency; vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
metabolic disturbances that, in the investigators judgment, might increase the risk to the
participant or decrease the chance of obtaining satisfactory data needed to achieve the
objectives of the study.
13) Participants who are unwilling or unable to follow protocol requirements.
14) Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or
squamous epithelial carcinomas of the skin that have been resected with no evidence of
metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is
considered cured with minimal risk of recurrence.
15) Prior known hypersensitivity reactions to and or any of their excipients.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with Conventional
Paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced
high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal
cancer.
Pre-dose (prior to the start of infusion), 0.167, 0.333, 0.500, 0.750, 1.000 (i.e. immediately after the
actual end of infusion), 1.333, 1.667, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000 and 36.000
Secondary Outcome
Outcome
TimePoints
To demonstrate population pharmacokinetic, safety and tolerability of IMP in participants with platinum-resistant refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal cancer
Pre-dose (prior to the start of infusion), 0.167, 0.333, 0.500, 0.750, 1.000 (i.e. immediately after the actual end of infusion), 1.333, 1.667, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000 and 36.000
Target Sample Size
Total Sample Size="166" Sample Size from India="166" 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
Phase 3
Date of First Enrollment (India)
28/10/2025
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="11" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
To establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with Conventional Paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal cancer and to demonstrate population pharmacokinetic, safety and tolerability of IMP in participants with platinum-resistant refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and/or primary peritoneal cancer.