Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer

NCT06815497 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY0200259924WIL599
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival is defined as the time between the initiation of telmisartan to progression, as defined by RECIST criteria, on a computed tomography scan.

  48 months

Secondary Outcomes (2)

• Treatment tolerability

  24 months

• Circulating tumor DNA changes

  24 months

Study Arms (1)

Telmisartan with Standard of Care Treatment

EXPERIMENTAL

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

Drug: Telmisartan

Interventions

Telmisartan DRUG

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

Also known as: Micardis

Telmisartan with Standard of Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tyler J Curiel: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (2)

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756, United States

RECRUITING

Dartmouth-Hitchcock Manchester

Manchester, New Hampshire, 03104, United States

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ivy Wilkinson-Ryan, MD

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla Fay

CONTACT

603-650-5000; AskClinicalTrials@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): May 14, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (2)