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

33 Participants Needed

Trial Summary

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.

How does the drug Telmisartan differ from other treatments for ovarian cancer?

Telmisartan is unique for ovarian cancer treatment as it is primarily an angiotensin receptor blocker used for high blood pressure, and its repurposing aims to overcome chemoresistance, offering a novel approach compared to traditional chemotherapy options. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ivy Wilkinson-Ryan, MD

Principal Investigator

Dartmouth Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Angiotensin-converting enzyme inhibitors for ovarian cancer? - a new adjuvant option or a silent trap. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Phase 1/2 study of atrasentan combined with pegylated liposomal doxorubicin in platinum-resistant recurrent ovarian cancer. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation BRCA1-Del ex9-12. [2022]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status in the ORZORA trial. [2023]