Temsirolimus for Peripheral Artery Disease

(TANGO-3 Trial)

Recruiting at 1 trial location

Overseen By Kirk Seward, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mercator MedSystems, Inc.

Must not be taking: Immunosuppressives, Immunotherapy, Chemotherapy

Disqualifiers: Pregnancy, CNS tumor, Myocardial infarction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-revascularization

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Temsirolimus (also known as Torisel or CCI-779) for people with peripheral artery disease (PAD), a condition that affects blood flow to the legs and feet. The researchers aim to determine if Temsirolimus can reduce the need for major amputations and other surgeries after a procedure to open blocked arteries below the knee. Participants will receive either Temsirolimus or a placebo (a substance with no active drug) following their artery procedure. The trial seeks individuals with severe pain or limb problems due to PAD who have recently undergone successful artery-opening procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that temsirolimus is generally safe and well-tolerated. One study found that when temsirolimus was used, blood vessels remained open longer, and there were fewer problems at the treatment site compared to those who did not receive it. This suggests the treatment is effective and causes few issues.

Temsirolimus has also been studied for other conditions, and while those results do not directly pertain to this treatment, they suggest it is likely safe. However, like any treatment, some side effects may occur. Always consult your doctor to understand the risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peripheral artery disease?

Unlike the standard treatments for Peripheral Artery Disease (PAD), such as lifestyle changes, medications like statins, or surgical procedures like angioplasty, Temsirolimus offers a unique approach. It is delivered directly to the adventitia and perivascular tissue after revascularization, targeting the area most in need of intervention. This localized delivery could potentially reduce restenosis, the re-narrowing of blood vessels, by directly affecting the cells responsible for the growth of scar tissue. Researchers are excited about Temsirolimus because it operates through a distinct mechanism that inhibits the mTOR pathway, which is crucial in cell growth and proliferation, potentially offering enhanced outcomes for PAD patients.

What evidence suggests that Temsirolimus might be an effective treatment for peripheral artery disease?

Research has shown that Temsirolimus, which participants in this trial may receive, can help treat peripheral artery disease (PAD). One study found that patients who took Temsirolimus experienced better blood flow in their vessels compared to those who did not. Another study demonstrated a 13.9% reduction in the narrowing of blood vessels, indicating that the vessels remained more open. These findings suggest that Temsirolimus helps keep arteries open and reduces the need for additional procedures in patients with PAD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with severe leg artery blockages (Rutherford 3-5) who have not had more than two previous treatments on the same spot. They must be able to understand and follow the study's procedures, agree to use effective contraception if female and of reproductive potential, and have a lesion in a specific part of the leg artery.

Inclusion Criteria

My leg pain is severe when walking or I have a serious limb-threatening condition.

My blood vessel's normal size is between 2mm and 8mm.

More than half of my targeted lesion is below my knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Temsirolimus or placebo delivered to adventitia and perivascular tissue after primary revascularization

Immediate post-revascularization

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits at 1, 6, 12, 24, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Temsirolimus

Trial Overview The trial tests Temsirolimus injected around blood vessels versus a saline placebo after leg artery revascularization procedures. It aims to see if Temsirolimus can reduce amputations, repeat surgeries, or blockages at six months post-procedure, with safety checked at one month and long-term follow-up for five years.

How Is the Trial Designed?

Group I: Temsirolimus Active Control 1 Intervention

Temsirolimus delivered to adventitia and perivascular tissue after primary revascularization

Group II: Placebo Placebo Group 1 Intervention

Saline placebo delivered to adventitia and perivascular tissue after primary revascularization

Temsirolimus is already approved in European Union, United States for the following indications:

Approved in European Union as Torisel for:

• Renal cell carcinoma

Approved in United States as Torisel for:

• Advanced renal cell carcinoma

Who Is Running the Clinical Trial?

Mercator MedSystems, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Citations

1. reporter.nih.gov reporter.nih.gov/search/lzbDW5rRp0yTP2pKtmX-Hg/project-details/11004996

RePORT RePORTER - National Institutes of Health (NIH) | Left untreated, up to 40% of patients with CLTI will require major (above the ankle) amputation within 6 months [4]. CLTI is often associated with multivessel ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04433572

Study Details | NCT04433572 | Temsirolimus Adventitial ... A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2007/022088s000_MedR.pdf

Drug: TORISEL (TEMSIROLIMUS) - accessdata.fda.gov The evaluations of PFS (time from randomization to disease progression or death) and ORR, were based on blinded independent radiologic.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36320143/

Temsirolimus Adventitial Delivery to Improve ANGiographic ... The therapy was safe and effective. Compared with controls, vessel lumen area patency was improved, and target lesion failure was less frequent.

5. researchgate.net researchgate.net/publication/365046488_Temsirolimus_Adventitial_Delivery_to_Improve_ANGiographic_Outcomes_Below_the_Knee

Temsirolimus Adventitial Delivery to Improve ANGiographic ... The principal analysis on the per protocol (PP) group of 53 patients revealed superior primary efficacy of the treatment arm, with reduction in TVAL% of 13.9% ...

6. go.drugbank.com go.drugbank.com/indications/DBCOND0126962/clinical_trials/DB06287?phase=3&status=recruiting

Peripheral Artery Disease(PAD) Recruiting Phase 3 Trials ... NCT04433572. Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee, Treatment.

7. fda.gov fda.gov/files/drugs/published/22088-Temsirolimus-Clinical-BPCA.pdf

22088 Temsirolimus Clinical BPCA 7.3 Major Safety Results ... The interpretation of the safety data for temsirolimus in pediatric patients is limited by the single.