Lenvatinib for Adenoid Cystic Carcinoma

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

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing lenvatinib, a pill that aims to stop cancer cells from growing and reduce their blood supply, in patients with adenoid cystic carcinoma. Researchers want to see if it can shrink the tumors by at least one-quarter. Lenvatinib has shown promise in treating various solid tumors, including adenoid cystic carcinoma.

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 lenvatinib generally safe for humans?

Lenvatinib has been used in treating various cancers, and while it shows promise, it can have side effects like high blood pressure, diarrhea, tiredness, decreased appetite, and weight loss. These side effects are common with drugs targeting blood vessel growth in tumors, and doctors usually monitor and manage them to help improve patient comfort and treatment success. ^{1 2 3 4 5}

How is the drug lenvatinib different from other treatments for adenoid cystic carcinoma?

Lenvatinib is unique because it is a multi-kinase inhibitor, which means it targets multiple pathways that help cancer cells grow, unlike traditional chemotherapy that targets rapidly dividing cells. This makes it a novel option for adenoid cystic carcinoma, a cancer with limited effective treatments. ^{1 3 6 7 8}

What data supports the effectiveness of the drug Lenvatinib for treating adenoid cystic carcinoma?

Lenvatinib, a drug that targets multiple pathways involved in cancer growth, has shown some effectiveness in treating adenoid cystic carcinoma (ACC). In a study, 52.4% of patients had stable disease, meaning their cancer did not get worse, and the median time patients stayed on the treatment was 4 months. ^{1 3 6 8 9}

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

Phase II Study of Lenvatinib in Patients With Progressive, Recurrent or Metastatic Adenoid Cystic Carcinoma. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Centralised RECIST Assessment and Clinical Outcomes with Lenvatinib Monotherapy in Recurrent and Metastatic Adenoid Cystic Carcinoma. [2021]

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

A Phase II Study of Dovitinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Adenoid cystic carcinoma of the salivary glands: a pilot study of potential therapeutic targets and characterization of the immunological tumor environment and angiogenesis. [2023]

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

A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Lenvatinib in Management of Solid Tumors. [2021]

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

Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. [2019]

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

Vandetanib inhibits growth of adenoid cystic carcinoma in an orthotopic nude mouse model. [2022]

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

Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma. [2015]