No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
Tyler J Curiel · Other
Who this trial is looking for
This trial is looking for adult women with a specific type of ovarian cancer that hasn't responded to standard treatments. Participants will take a medication called telmisartan along with other chemotherapy drugs while being monitored for their health.
Are You a Good Fit for This Trial?
Must not be takingLithiumRituximabAmifostineRamiprilBevacizumab
Rules you outCongestive heart failureActive serious infectionSignificant liver disease
You may be able to join if
I am at least 18 years old.
I can provide informed consent.
I have high-grade serous ovarian cancer.
I have platinum-resistant ovarian cancer.
I can take approved chemotherapy for my cancer.
I expect to live for at least 2 more months.
My organ functions are adequate.
You may not be able to join if
I cannot provide informed consent.
I have significant liver disease.
I have high blood pressure emergencies.
I am incarcerated or homeless.
I am pregnant or breastfeeding.
I am under 18 years old.
I have an active serious infection.
I have serious heart problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care chemotherapy regimens versus historical controls.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Able and willing to provide informed consent.
* Histologically proven high-grade serous ovarian carcinomas (HGSOC)
* Platinum-resistant or refractory ovarian cancer (OC) defined as p…
Inclusion Criteria:
* ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Able and willing to provide informed consent.
* Histologically proven high-grade serous ovarian carcinomas (HGSOC)
* Platinum-resistant or refractory ovarian cancer (OC) defined as progression of disease on carboplatin or growth of disease as detected on computed tomography (CT) scan within 6 months of last platinum treatment
* To receive the allowable standard of care (SOC) chemotherapy regimens for OC
* Life expectancy ≥2 months
* Adequate organ and bone marrow reserve function as indicated by the following:
* Adequate hematological function, defined as absolute neutrophil count (ANC) ≥1.5 x 10\^9/L, platelet count ≥100 x 10\^9/L, and hemoglobin ≥8 g/dL without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement)
* Adequate liver function, defined as total bilirubin level ≥1.5 x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) ≤ 2.5 x IULN, and alanine aminotransferase (ALT) ≤ 2.5 x IULN
* Adequate renal function defined as creatinine ≤ 1.5 x IULN or measured or calculated creatinine clearance ≥ 40 mL/min per institutional standard. Assessment methods must be recorded.
* Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time ≤ 1.5 x IULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x IULN (unless patient receiving anticoagulant therapy).
* Female patients of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on this study and for at least 3 months after the last dose of chemotherapy
* FCBP must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:
* ≥ 45 years of age and has not had menses for \>1 year
* Amenorrheic for \> 2 years without a hysterectomy and/or oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
* Status is post-hysterectomy, -oophorectomy, or -tubal ligation
* Genetic defect precluding pregnancy
* No contraindication to telmisartan\*, including angiotensin converting enzyme (ACE) inhibitor use in the 6 weeks prior to telmisartan start on trial
* Systolic blood pressure maintained at ≥ 110 mm Hg during study enrollment assessment and throughout the study.
Exclusion Criteria:
Patients who meet any of the criteria below may NOT be eligible to participate in this study:
* Patients who are unable to provide informed consent.
* Patients with known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they must have an undetectable HCV viral load
* Hypertensive urgency or emergency as defined
* Incarcerated or homeless
* Pregnant or lactating.
* Individuals who are not yet adults \<18 years of age.
* On lithium therapy in any form
* Received rituximab or amifostine within 30 days prior to first telmisartan dose on this study
* Active, serious infection requiring treatment
* Clinically significant (i.e., active) cardiovascular disease, cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication
* History or current evidence of any condition, therapy, and active infections, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
* Taking ramapril
* Using bevacizumab as part of their SOC chemotherapy regimen
* If known to be HIV-infected, have undetectable HIV viral load by any accepted standard of care HIV detection method
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