Platinum-Resistant Primary Peritoneal CarcinomaPhase 3NCT06867562
Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer
A Phase 3 study testing Paclitaxel Lipid Suspension and Conventional paclitaxel or Taxol in people with Platinum-Resistant Primary Peritoneal Carcinoma and Platinum Resistant High Grade Epithelial Ovarian Cancer, run by Jina Pharmaceuticals Inc..
Trial summary
This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-Resistant Primary Peritoneal Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer, Platinum Resistant High Grade Serous Ovarian Cancer
- What is being tested?
- Paclitaxel Lipid Suspension and Conventional paclitaxel or Taxol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is willing to give written signed and dated informed consent to participate in the study.
- Female ≥18 years of age fulfilling all other eligibility criteria.
- 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 (<50% 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.
- 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.
- 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.
- Have at least one measurable lesion as per the RECIST criteria (version 1.1).
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Left Ventricular Ejection fraction (LVEF) ≥50% as per Echocardiography (ECHO).
- Participant has recovered from adverse events (baseline or ≤ 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.
- Participants with life expectancy of at least 6 months in the Investigator's opinion.
- 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) OR
- Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of <1% per year) for at least 6 months after the last 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.
- Participants with adequate bone marrow, renal and hepatic function
- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.
- 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).
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- 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
- Uncontrolled diabetes (defined as HbA1c ≥8% as per ADA) or has an active infection requiring systemic therapy.
- History of drug or alcohol abuse according to medical history assessment by the investigator within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening.
- 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.
- 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.
- Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE v5.0 criteria.
- History of clinically significant liver or renal insufficiency; vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that, in the investigator's judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- Participants who are unwilling or unable to follow protocol requirements.
- 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.
- Prior known hypersensitivity reactions to and/or any of their excipients.
About this study
Official title: 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
This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer.
Paclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg/m2 on Day 1, Day 8 and Day 15 of each 28 days cycle.
Read more
The primary objective is 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.
Participants in both arms will be dosed with the drug until disease progression as assessed by investigator and/or unacceptable toxicity.
- Conditions
- Platinum-Resistant Primary Peritoneal Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer, Platinum Resistant High Grade Serous Ovarian Cancer
- Being tested
- Paclitaxel Lipid Suspension, Conventional paclitaxel or Taxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Lipid SuspensionDrug
The formulation consists of uniformly sized (< 100 nm) particles of Paclitaxel suspended in a lipid-based formulation. The advantage of such a Lipid-Based formulation of Paclitaxel is an improvement of the safety profile by eliminating excipients, Cremophor and ethanol which are present in conventional Paclitaxel formulations (Taxol®).
Conventional paclitaxel or TaxolDrug
Conventional formulation with detergent Cremophor and alcohol
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Lipid Suspension for Injection | Experimental | Participants will be administered Paclitaxel Lipid Suspension infusion at a dose of 80 mg/m2 for over 1 hour on days 1, 8 and 15 of each cycle. The cycle length for the Paclitaxel Lipid Suspension weekly schedule is 28 days. Receives: Drug: Paclitaxel Lipid Suspension |
| Conventional paclitaxel | Active comparator | Participants will be administered Conventional Paclitaxel infusion at a dose of 80 mg/m2 for over 1 hour on days 1, 8 and 15 of each cycle. The cycle length for the Paclitaxel Lipid Suspension weekly schedule is 28 days. Receives: Drug: Conventional paclitaxel or Taxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate
The proportion of participants whose Best Overall Response is a confirmed CR or PR as determined by blinded independent central review (BICR) based on RECIST v1.1
Measured: Minimum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-Resistant Primary Peritoneal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At baseline, participants will be randomized to either the Paclitaxel Lipid Suspension arm or the Conventional Paclitaxel arm. Participants in both arms will continue the treatment till either disease progression as assessed by investigator. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and Gynecologic Cancer Intergroup (GCIG) Cancer Antigen 125 guidelines. To ensure consistent interpretation of measurable disease and objective endpoints for the study, all imaging studies performed throughout the study will be sent to a blinded independent central review (BICR) vendor for tumor measurement and evaluation of response.
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jina Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867562
- Sponsor's protocol ID
- 0127-23
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06867562
- Acronym / sponsor ID
- 0127-23
- Conditions
- Platinum-Resistant Primary Peritoneal Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer, Platinum Resistant High Grade Serous Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Jina Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer.
Paclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg/m2 on Day 1, Day 8 and Day 15 of each 28 days cycle.
The primary objective is 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.
Participants in both arms will be dosed with the drug until disease progression as assessed by investigator and/or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At baseline, participants will be randomized to either the Paclitaxel Lipid Suspension arm or the Conventional Paclitaxel arm. Participants in both arms will continue the treatment till either disease progression as assessed by investigator. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and Gynecologic Cancer Intergroup (GCIG) Cancer Antigen 125 guidelines. To ensure consistent interpretation of measurable disease and objective endpoints for the study, all imaging studies performed throughout the study will be sent to a blinded independent central review (BICR) vendor for tumor measurement and evaluation of response.
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Lipid Suspension for Injection | Experimental | Drug: Paclitaxel Lipid SuspensionParticipants will be administered Paclitaxel Lipid Suspension infusion at a dose of 80 mg/m2 for over 1 hour on days 1, 8 and 15 of each cycle. The cycle length for the Paclitaxel Lipid Suspension weekly schedule is 28 days. |
| Conventional paclitaxel | Active comparator | Drug: Conventional paclitaxel or TaxolParticipants will be administered Conventional Paclitaxel infusion at a dose of 80 mg/m2 for over 1 hour on days 1, 8 and 15 of each cycle. The cycle length for the Paclitaxel Lipid Suspension weekly schedule is 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The participant is willing to give written signed and dated informed consent to participate in the study.
- Female ≥18 years of age fulfilling all other eligibility criteria.
- 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 (<50% 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.
- 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.
- 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.
Key exclusion criteria (24 listed)
- 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.
- 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.
- 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.
- Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Lipid SuspensionThe formulation consists of uniformly sized (< 100 nm) particles of Paclitaxel suspended in a lipid-based formulation. The advantage of such a Lipid-Based formulation of Paclitaxel is an improvement of the safety profile by eliminating excipients, Cremophor and ethanol which are present in conventional Paclitaxel formulations (Taxol®). | Drug | Paclitaxel Lipid Suspension for Injection |
| Conventional paclitaxel or TaxolConventional formulation with detergent Cremophor and alcohol | Drug | Conventional paclitaxel |
Primary outcome
Confirmed Objective Response Rate
Time frame: Minimum 6 months
The proportion of participants whose Best Overall Response is a confirmed CR or PR as determined by blinded independent central review (BICR) based on RECIST v1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel Lipid Suspension and Conventional paclitaxel or Taxol in people with Platinum-Resistant Primary Peritoneal Carcinoma and Platinum Resistant High Grade Epithelial Ovarian Cancer, run by Jina Pharmaceuticals Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (time frame: Minimum 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.