Lenvatinib for Adenoid Cystic Carcinoma

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Lenvatinib, Anticoagulants

Disqualifiers: Uncontrolled hypertension, Cardiac 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

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: 4

Duration: Until disease progression or unacceptable toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lenvatinib, an oral drug, to determine its effectiveness in shrinking adenoid cystic carcinoma, a type of cancer. Researchers aim to see if lenvatinib can reduce the cancer's size by at least one-quarter. The trial seeks to understand the drug's positive and negative effects on both patients and the cancer. Individuals with adenoid cystic carcinoma that has recurred or spread, and who cannot undergo surgery or radiation for a cure, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that at least 2 weeks have passed since your last systemic treatment (4 weeks for certain treatments) before starting the study drug. You cannot take other anti-cancer therapies while participating in the trial, but some medications for bone metastases and palliative radiation are allowed.

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

Research shows that lenvatinib is generally well-tolerated by patients with adenoid cystic carcinoma. Studies have found that lenvatinib can effectively shrink tumors. In terms of safety, researchers have tested lenvatinib in various situations. While some side effects were observed, they are typical for cancer treatments.

Common side effects include high blood pressure and tiredness, but these can often be managed. More serious side effects can occur, but they are less common. Data from previous studies suggest that, although there are risks, many patients can safely take lenvatinib with proper monitoring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lenvatinib is unique because it targets the blood vessels that supply tumors, which is different from the usual treatments for adenoid cystic carcinoma that focus on surgery or radiation. Unlike standard care options, lenvatinib is a tyrosine kinase inhibitor that works by blocking certain proteins, thereby preventing tumor growth and spread. Researchers are excited about lenvatinib because it offers a new approach that could control the disease more effectively and offers the convenience of an oral medication, which can be easier for patients to manage.

What evidence suggests that lenvatinib might be an effective treatment for adenoid cystic carcinoma?

Research has shown that lenvatinib, the treatment under study in this trial, may help treat adenoid cystic carcinoma. In one study, 66% of patients experienced tumor shrinkage, with 25% seeing a reduction of 20% or more in tumor size. Another study found that 21.7% of patients had a noticeable decrease in cancer size. Lenvatinib has also proven effective in real-world situations, confirming its ability to combat this type of cancer. These findings suggest lenvatinib could help reduce tumor size in patients with adenoid cystic carcinoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with measurable adenoid cystic carcinoma, good performance status, and proper organ function can join. They must have tried other treatments without success and not used lenvatinib before. Participants need available tumor tissue for study, no recent major surgeries or bleeding events, stable blood pressure without severe medication, and agree to use contraception.

Inclusion Criteria

Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)

My blood counts meet the required levels without transfusions.

Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion Criteria

I haven't had a stroke, clot, or embolism in the last 6 months.

I do not have symptoms from brain or spinal cord tumor spread.

I haven't had major surgery or a serious injury in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenvatinib at a starting dose of 24 mg daily taken orally for each 4-week cycle

Until disease progression or unacceptable toxicity

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lenvatinib

Trial Overview The trial is testing the effects of an oral drug called Lenvatinib on shrinking adenoid cystic carcinoma tumors by at least one-quarter. It's a phase II study to see if this drug can slow down cancer growth by disrupting the cancer cells' functions and cutting off their blood supply.

How Is the Trial Designed?

Group I: Lenvatinib Experimental Treatment 1 Intervention

All eligible patients will receive a starting lenvatinib dose of 24 mg daily taken orally for each 4-week cycle. Patients may remain on study until progression of disease or unacceptable toxicity. Alternatively, Lenvatinib may be dissolved in fluid per the Food and Drug Administration (FDA) label and administered orally or via a feeding tube.

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

Approved in United States as Lenvima for:

• Differentiated Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Lenvima for:

• Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Kisplyx for:

• Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Published Research Related to This Trial

Lenvatinib is an effective multikinase inhibitor approved for treating radioiodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma, showing favorable efficacy in various malignancies.

While lenvatinib has beneficial effects, it is associated with common adverse events like hypertension and fatigue, necessitating careful monitoring and management to enhance patient quality of life and treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. Cabanillas, ME., Takahashi, S.[2019]

Vandetanib effectively inhibits the growth of adenoid cystic carcinoma (ACC) both in vitro and in vivo, demonstrating its potential as a novel treatment option for this cancer.

In a study involving nude mice with ACC tumors, vandetanib treatment resulted in significantly reduced tumor volumes and increased apoptosis in tumor and endothelial cells, indicating its efficacy in targeting the disease's growth mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vandetanib inhibits growth of adenoid cystic carcinoma in an orthotopic nude mouse model. Choi, S., Sano, D., Cheung, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6599407/

Phase II Study of Lenvatinib in Patients With Progressive ... The majority of patients (21 of 32 patients; 66%) experienced tumor regression; eight (25%) of 32 patients had 20% or greater reduction in tumor size, listed in ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.28124?af=R

Lenvatinib in Relapsed/Metastatic Adenoid Cystic ... Our data have confirmed the activity and safety of lenvatinib in a real-world setting. Lenvatinib achieved an ORR of 21.7%; no complete response ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40033633/

Lenvatinib in Relapsed/Metastatic Adenoid Cystic Carcinoma Forty-six patients (90%) were evaluated for response: the ORR was 21.7%, with 10 patients achieving a partial response; 24 patients had a stable disease ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1040842822003109

Drug-based therapy for advanced adenoid cystic carcinoma Apatinib, Axitinib and Lenvatinib showed most promising results. •. Translational research is important for the development of target therapies.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.6086

Phase II study on lenvatinib (LEN) in recurrent and/or ... Among 26 evaluable pts, partial responses were 3 (11.5%) (3/26). Target lesions reduction between 23% and 28% was observed in 4 out 20 pts with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02860936

Study Details | NCT02860936 | Lenvatinib in Recurrent ... Safety and toxicity profile of lenvatinib (according to CTCAE v 4.0), Incidence of adverse events (AEs), will be graded according to the National Cancer ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.18.01859

Phase II Study of Lenvatinib in Patients With Progressive ... This trial met the prespecified overall response rate primary end point, demonstrating antitumor activity with lenvatinib in R/M ACC patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8431195/

Centralised RECIST Assessment and Clinical Outcomes with ... We aimed to summarise the real-world experience of lenvatinib use in ACC patients in the UK and found that although some patients obtained clinical benefit,