Losartan and Paclitaxel for Platinum-Resistant Ovarian Cancer
This study is testing a combination of two drugs, losartan and paclitaxel, for people with platinum-resistant ovarian cancer. Platinum-resistant means the cancer has not responded well to platinum-based chemotherapy. Researchers want to see how many people respond to this treatment. You may be able to join if you are an adult woman with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that can be measured. This study is currently recruiting about 27 participants. Losartan is approved for other uses but not yet for ovarian cancer, while paclitaxel is an approved treatment for ovarian cancer. This study is looking at how well the combination works together.
- Study design
- This is a single-arm, open-label study, meaning all participants receive the same treatment and everyone knows which treatment is being given. About 27 people are expected to join this study.
- What's involved
- You will receive losartan by mouth once daily and paclitaxel through an IV on days 1, 8, and 15 of a 21-day cycle. Treatment continues until your disease progresses, you withdraw, or you experience unacceptable side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- If you stop treatment due to disease progression, you will be followed for 30 days. If you stop due to side effects, you will have visits and scans every 9 weeks until you start a different treatment.
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NCT07265739
Losartan and Paclitaxel in Platinum Resistant Ovarian Cancer
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~27 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:losartanPaclitaxel
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Screening through end of treatment, estimated 24 months total.
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Oladapo Yeku, MD, Ph.D., FACP · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
The subject must be 18 years of age.
Subjects with histologically/cytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Subjects with mucinous carcinoma and low-grade serous carcinoma are not eligible.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Subject has adequate organ function at screening:
Prior to study Day 1 (first study treatment administration), subject must be:
Subjects must have platinum resistant ovarian cancer defined as disease recurrence \< 6 months after completion of a platinum-containing regimen. Patients with primary platinum refractory disease are eligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy).
Subjects will have received ≤4 prior lines for platinum resistant ovarian cancer (PROC); maintenance bevacizumab or poly adenosine diphosphate-ribose polymerase (PARP) are not included as a line of therapy.
Subjects who are eligible for bevacizumab, mirvetuximab, or PARP inhibitor therapy must have received these treatments. For patients who are ineligible for these treatments or those who decline, this must be documented in the records.
Exclusion
Has adverse events (AEs) from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except alopecia.
Subjects with asymptomatic central nervous system (CNS) metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 3 months.
Impaired cardiac function or clinically significant cardiac disease.
Active infection requiring therapy or has a known history of positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody with detected Hepatitis C virus (HCV) RNA. No testing for Hepatitis B or Hepatitis C is required.
Received a live vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study.
Females who are pregnant or breastfeeding.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to paclitaxel.
Grade 2 peripheral neuropathy at baseline or screening.
Essential hypertension or any other condition currently being treated with an angiotensin-converting enzyme (ACE)/angiotensin II receptor blockers (ARB) inhibitor, calcium channel blocker, diuretic or any other antihypertensive agent.
Subjects with a history of orthostasis or syncope.
Subjects with a history of hypersensitivity, allergy or intolerance to ACE/ARB inhibitors.
Subjects with baseline systolic blood pressure ≤ 95 or diastolic blood pressure ≤ 60 obtained on two separate days prior to study enrollment.
Subjects with uncontrolled hypertension at baseline defined as systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110 on two readings obtained on two separate days prior to study enrollment.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical trial (e.g., substance abuse; psychiatric disturbance; or uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism).
Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the subject inappropriate for entry into the study.
What this trial measures
- Overall Response Rate (ORR)Screening through end of treatment, estimated 24 months total.
ORR will be determined as the number of patients with a partial response (PR) or complete response (CR) to therapy by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.