Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer
NCT ID: NCT06815497
Last Updated: 2026-01-28
Study Results
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Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2026-01-21
2029-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Telmisartan with Standard of Care Treatment
oral telmisartan in combination with standard of care chemotherapy. chemotherapy regimen is preferably doxorubicin (preferably liposomal doxorubicin) but paclitaxel, nab-paclitaxel, or docetaxel are allowed per investigator or patient preference
Telmisartan
Telmisartan will be introduced as a 40 mg tablet to be taken orally once daily. In participants not experiencing telmisartan dose limiting toxicity, the dose will be escalated to a maximum of 80 mg
Interventions
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Telmisartan
Telmisartan will be introduced as a 40 mg tablet to be taken orally once daily. In participants not experiencing telmisartan dose limiting toxicity, the dose will be escalated to a maximum of 80 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Tyler J Curiel
OTHER
Responsible Party
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Tyler J Curiel
Professor of Medicine
Principal Investigators
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Ivy Wilkinson-Ryan, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth Health
Locations
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Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Dartmouth-Hitchcock Manchester
Manchester, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Ivy Wilkinson-Ryan, MD
Role: primary
References
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Other Identifiers
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24WIL599
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY02002599
Identifier Type: -
Identifier Source: org_study_id
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