ClinicalTrials.gg
Not yet recruitingNCT07265739Updated Sep 22, 2026

Losartan and Paclitaxel in Platinum Resistant Ovarian Cancer

A Phase 2 interventional study of losartan and Paclitaxel in Platinum Resistant Ovarian Cancer, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 71 studies testing paclitaxel in Carcinoma, Ovarian Epithelial — 2 open to participants now, 3 under way, 1 of them phase 3. Paclitaxel · Carcinoma, Ovarian Epithelial.

Planned enrollment
41st of 60
27 · median 47
Started
2027
the only one that year
Phase 2
28 of 71
1 open now
Registered
71st of 71
by date

Among the 71 studies testing paclitaxel in Carcinoma, Ovarian Epithelial, this one is the 41st largest by planned enrollment of the 60 interventional ones that give a count, is the only one that started in 2027, is one of 28 in phase 2, and was the 71st registered.

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

Browse Carcinoma, Ovarian Epithelial studies →

Open to participants now

2 of the 71 studies testing paclitaxel in Carcinoma, Ovarian Epithelial are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About paclitaxel

Paclitaxel: first FDA approval 1992 (TAXOL), first EMA approval 1999. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 71 studies testing paclitaxel in Carcinoma, Ovarian Epithelial, or all of them as a file.
02

Study summary

The purpose of this Phase II study is to measure the effects of a combination of study drugs, losartan and paclitaxel, on platinum resistant ovarian cancer.

Read the detailed description

This is a prospective, single-arm, open label study of daily oral losartan in combination with intravenous weekly paclitaxel in patients with platinum resistant ovarian cancer. The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival.

The U.S. Food and Drug Administration (FDA) has not approved losartan for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved paclitaxel as a treatment option for this disease. This research study involves screening for eligibility, study treatment with the study drugs, and study visits. Participants will receive study treatment until disease progression, withdrawal, or unacceptable side effects are experienced. Participants that stop study treatment due to disease progression will be followed for 30 days. Participants that stop study treatment due to an unacceptable side effect will have visits and imaging scans every 9 weeks until a different treatment is started. It is expected that about 27 people will take part in this research study.

03

Conditions studied

  • Platinum Resistant Ovarian Cancer

Keywords

  • Platinum Resistant Ovarian Cancer
  • epithelial ovarian carcinoma
  • fallopian tube carcinoma
  • primary peritoneal carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The subject must be 18 years of age.
  • Subjects with histologically/ 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 , 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, 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 (ECOG) performance status 0-2.
  • Subject has adequate organ function at screening:

    i) (ANC) ≥ 1000/mm3 without the use of hematopoietic growth factors.

ii) count ≥ 75,000/mm3. iii) ≥ 8.0 g/dL (must be at least 1 weeks post-red blood cell transfusion and not receiving erythropoietic-stimulating agents).

iv) total ≤ 1.5 × the (ULN). For subjects with documented Gilbert's disease, total bilirubin ≤ 3.0 mg/dL is allowed.

v) serum albumin ≥ 2.5 g/dL vi) serum (CrCl) ≥ 40 mL/min, using Cockcroft and Gault vii) (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN in the absence of documented liver ; ≤ 5 x ULN in the presence of liver metastases.

  • Prior to study Day 1 (first study treatment administration), subject must be:

    i) at least 4 weeks after the most recent biologic (antibody-based) or immunotherapy ii) at least 2 weeks after any prior chemotherapy or targeted small molecule therapy

  • Subjects must have platinum resistant ovarian cancer defined as disease recurrence \< 6 months after completion of a platinum-containing regimen. Patients with primary platinum disease are eligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 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 criteria

Exclusion Criteria:

  • 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) are eligible provided they have been clinically stable and not requiring 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 cardiac disease.
  • Active infection requiring therapy or has a known history of positive surface antigen (HBsAg) or positive antibody with detected Hepatitis C virus (HCV) RNA. No testing for Hepatitis B or Hepatitis C is required.
  • Received a 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 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.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Losartan + Paclitaxel

    Once daily oral losartan combined with paclitaxel administered intravenously once weekly. Each cycle is 21 days and participants may receive study treatment until disease progression or withdrawal. Losartan and paclitaxel are administered at a pre-determined dose.

    Drug: losartan · Drug: Paclitaxel

Interventions

  • Treatment with losartan will be administered orally once daily starting on day 1 of every 21-day cycle and will be taken continuously throughout the cycle. Losartan is administered at 25 mg a day for the first 7 days of cycle 1. Losartan may be increased to 50 mg daily on day 8 if systolic blood pressure ≥ 120 mm Hg.

  • Paclitaxel 80 mg/m2 will be administered as a 60-min intravenous infusion after any premedication as per institutional guidelines. A ramp-up infusion rate is also acceptable as per institutional guidelines. Paclitaxel will be administered on days 1, 8 and 15 of a 21-day cycle and treatment will continue until unacceptable toxicity or disease progression.

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    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.

    Time frame: Screening through end of treatment, estimated 24 months total.

Secondary outcomes

  1. Progression free survival (PFS)

    The time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Response is evaluated using RECIST 1.1.

    Time frame: Screening through end of treatment, estimated 24 months total

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Principal Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data can be shared no earlier than 1 year following the date of publication

Access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Dec 2027, 10 months later.

Of 51 phase 2 interventional studies under Carcinoma, Ovarian Epithelial, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 92. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2025
First posted
Dec 5, 2025
StartEst.
Feb 2027
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07265739
Collaborators
American Cancer Society, Inc.
Responsible party
Oladapo O. Yeku,M.D.,Ph.D. (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Dec 5, 2025
Start date
Feb 2027 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Oladapo Yeku, MD, Ph.D., FACP
Contact
Oyeku@mgh.harvard.edu
617-643-9354
Oladapo Yeku, MD, Ph.D., FACP
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Losartan · Paclitaxel

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