Phase II Non-Randomized, Unblinded, Single-Center Trial of Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer Versus Historical Best Supportive Care
Tyler J Curiel
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.
Description
This is an open label, single-arm Phase II trial of telmisartan plus selected standard of care chemotherapy regimens containing an anthracycline or taxane. The primary study objective is to assess progression-free survival.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 functi…
Interventions
- DrugTelmisartan
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
Locations (2)
- Dartmouth HitchcockLebanon, New Hampshire
- Dartmouth-Hitchcock ManchesterManchester, New Hampshire