Telmisartan for Ovarian Cancer

Overseen By Kayla Fay

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Tyler J Curiel

Must be taking: Standard chemotherapy

Must not be taking: Lithium, Ramapril, Bevacizumab

Disqualifiers: Liver disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of telmisartan, a medication typically used for high blood pressure, combined with standard chemotherapy treatments for ovarian cancer. The goal is to determine if this combination can extend the time patients live without their cancer worsening. It suits women with high-grade serous ovarian cancer that does not respond well to standard platinum-based treatments. Participants should be able to undergo standard chemotherapy and not have serious liver or heart conditions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use ACE inhibitors like ramapril or have taken rituximab or amifostine within 30 days before starting telmisartan. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that telmisartan is likely to be safe for humans?

Research has shown that telmisartan, a drug commonly used to treat high blood pressure, may slow the growth of ovarian cancer cells and even cause them to die in lab studies. Telmisartan is already FDA-approved for high blood pressure, indicating it has been tested for safety in humans for that purpose.

However, results regarding the safety of drugs like telmisartan have been mixed. Some studies suggested a slight increase in cancer risk with similar medications, but further research did not confirm this link. Thus, telmisartan is generally considered safe for high blood pressure, but its safety for cancer treatment remains under study.

As this trial is in a mid-stage phase, researchers are still evaluating the safety of telmisartan for treating ovarian cancer. Mid-stage trials often focus on understanding treatment tolerance, so researchers continue to collect data for its use in this context. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about telmisartan for ovarian cancer because it offers a novel approach by combining with standard chemotherapy treatments. Unlike traditional treatments that solely rely on chemotherapy agents like doxorubicin or paclitaxel, telmisartan is an angiotensin II receptor blocker, typically used for high blood pressure. Its unique mechanism may enhance chemotherapy effectiveness by potentially inhibiting cancer growth pathways and improving drug delivery to the tumor. This combination could lead to better outcomes for patients with ovarian cancer, offering new hope beyond current treatment options.

What evidence suggests that telmisartan might be an effective treatment for ovarian cancer?

Studies have shown that telmisartan might help fight ovarian cancer by stopping cancer cells from growing and causing them to die. Research suggests that telmisartan can strengthen the body's immune response to cancer and lower inflammation, which often links to cancer progression. Some studies have associated telmisartan with fewer cases of ovarian cancer recurrence. While more research is needed to confirm these benefits, early findings suggest that telmisartan could be promising when used with standard chemotherapy. Participants in this trial will receive telmisartan combined with standard-of-care chemotherapy, which may include doxorubicin, paclitaxel, nab-paclitaxel, or docetaxel. ^{2 4 6 7 8}

Who Is on the Research Team?

Ivy Wilkinson-Ryan, MD

Principal Investigator

Dartmouth Health

Are You a Good Fit for This Trial?

This trial is for women over 18 with high-grade serous ovarian cancer that's resistant to platinum-based chemotherapy. They must have a life expectancy of at least 2 months, be willing to use contraception, and have stable blood pressure. Excluded are pregnant or lactating women, those with significant heart conditions or infections, and anyone on certain medications like ACE inhibitors.

Inclusion Criteria

I am eligible for standard chemotherapy for ovarian cancer.

FCBP must have a negative serum pregnancy test at screening

My ovarian cancer is a high-grade serous type.

Exclusion Criteria

Pregnant or lactating

Incarcerated or homeless

If known to be HIV-infected, have undetectable HIV viral load by any accepted standard of care HIV detection method

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral telmisartan in combination with standard of care chemotherapy regimens

48 months

Regular visits for chemotherapy administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Periodic visits for monitoring progression-free survival and treatment tolerability

What Are the Treatments Tested in This Trial?

Interventions

• Telmisartan

Trial Overview

The study tests if adding Telmisartan to standard chemotherapy improves progression-free survival in patients compared to past data. Participants will receive Telmisartan alongside their regular chemo regimen and will be monitored for changes in the growth of their cancer.

How Is the Trial Designed?

Group I: Telmisartan with Standard of Care Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Tyler J Curiel

Lead Sponsor

Trials

2

Recruited

70+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

Olaparib, a PARP inhibitor, showed a 36% objective response rate in women with relapsed ovarian cancer and a germline BRCA1/2 mutation, even after they had undergone multiple lines of chemotherapy, indicating its efficacy in this challenging patient population.

The median duration of response to olaparib was 7.4 months, and the safety profile was consistent across patients who had received three or more lines of prior chemotherapy, with similar rates of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Matulonis, UA., Penson, RT., Domchek, SM., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06815497

Study Details | NCT06815497 | Telmisartan in Combination ...

The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26548340/

Telmisartan prevents proliferation and promotes apoptosis ...

In the present study, it was investigated whether telmisartan could exert anticancer effects on ovarian cancer cells through upregulating ...

3.

withpower.com

withpower.com/trial/telmisartan-for-ovarian-cancer-3d41d

Telmisartan for Ovarian Cancer · Info for Participants

Olaparib, a PARP inhibitor, showed a 36% objective response rate in women with relapsed ovarian cancer and a germline BRCA1/2 mutation, even after they had ...

4.

fjps.springeropen.com

fjps.springeropen.com/articles/10.1186/s43094-024-00655-9

Expanding telmisartan's therapeutic horizon: exploring its ...

This review explores the complex mechanisms of action of telmisartan and clarifies its effectiveness in an inflammation, cancer, metabolic, and CNS disorders.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7176948/

Impact of Angiotensin Receptor Blockers, Beta ...

In this study, ARBs use during primary treatment is associated with lower recurrence in EOC patients. However, CCBs, BBs, and TDs did not show beneficial ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8123393/

Antihypertensive Drug Use and the Risk of Ovarian Cancer ...

In vitro telmisartan, an angiotensin-receptor blocker, was demonstrated to inhibit cell proliferation and induce apoptosis in ovarian cancer ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5863774/

The Use of Telmisartan and the Incidence of Cancer - PMC

A meta-analysis reported an 8% increased risk of cancer with the use of angiotensin receptor blockers (ARBs), but subsequent meta-analyses and observational ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06815497?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Dartmouth-Hitchcock%20Medical%20Center%22))&rank=1

Telmisartan in Combination With Cytotoxic Regimens ...

The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care ...