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Tyrosine Kinase Inhibitor

Lenvatinib for Adenoid Cystic Carcinoma

Phase 2

Waitlist Available

Led By Alan Ho, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platelet count ≥ 100,000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.

Subject must be able to swallow and retain oral medication.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial is a phase II cancer study to test the effectiveness of the drug lenvatinib on adenoid cystic carcinoma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Lenvatinib may cause high blood pressure, fatigue, nausea, decreased appetite, kidney problems like protein in urine or failure requiring dialysis; it might also lead to serious cardiac conditions or increase the risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts meet the required levels without transfusions.

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I can swallow and keep down pills.

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I can take care of myself but might not be able to do heavy physical work.

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I have a tumor that can be measured with a scan.

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My cancer has returned or spread and cannot be removed by surgery or cured with radiation.

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I am 18 years old or older.

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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

best overall response rate (BOR)

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554

70%

Hypertension

70%

Diarrhoea

60%

Weight decreased

43%

Fatigue

43%

Stomatitis

40%

Arthralgia

40%

Proteinuria

40%

Nausea

37%

Decreased appetite

33%

Headache

33%

Asthenia

33%

Dysphonia

30%

Myalgia

30%

Palmar-plantar erythrodysaesthesia syndrome

30%

Abdominal pain upper

30%

Vomiting

27%

Cough

27%

Abdominal pain

27%

Dizziness

23%

Pain in extremity

20%

Alopecia

20%

Back pain

20%

Rash

20%

Dysgeusia

20%

Nasopharyngitis

17%

Constipation

17%

Muscle spasms

17%

Dyspnoea

17%

Epistaxis

17%

Platelet count decreased

17%

Pyrexia

13%

Hypotension

13%

Oropharyngeal pain

13%

Musculoskeletal pain

10%

Anaemia

10%

Paraesthesia

10%

Flank pain

10%

Dyspepsia

10%

Dysphagia

10%

Sinusitis

10%

Oedema peripheral

10%

Pelvic pain

10%

Urinary tract infection

10%

Hypocalcaemia

10%

Musculoskeletal chest pain

10%

Haemoptysis

10%

Depression

10%

Upper respiratory tract infection

10%

Insomnia

Skin fissures

Vitamin D deficiency

Ejection fraction decreased

Pneumonia

Hypomagnesaemia

Joint swelling

Bronchitis

Blood cholesterol increased

Dyspnoea exertional

Hyperhidrosis

Toothache

Hyperaesthesia

Sciatica

Gastrooesophageal reflux disease

Lung infection

Dermatitis acneiform

Hypothyroidism

Alanine aminotransferase increased

Dry skin

Flatulence

Productive cough

Non-cardiac chest pain

Abdominal distension

Gingival pain

Gastrointestinal infection

Pain

Lipase increased

Blood calcium increased

Electrocardiogram T wave inversion

Hypoalbuminaemia

Dementia

Varicose vein

Thermal burn

Blood creatinine increased

Electrocardiogram QT prolonged

Post procedural haemorrhage

Pathological fracture

Syncope

Cerebrovascular accident

Phlebitis infective

Haemorrhoids

Cholecystitis acute

Gastroenteritis

Delirium

General physical health deterioration

Dry mouth

Hyponatraemia

Dehydration

Coronary artery occlusion

Lymph gland infection

Metastatic pain

Transient ischaemic attack

Hydrocholecystis

Vasculitis

Hyperglycaemia

Neck pain

Thrombocytopenia

Malaise

100%

80%

60%

40%

20%

Study treatment Arm

OOL, Treatment Period: Lenvatinib 20 mg

Randomization Phase: Lenvatinib 24 mg

Randomization Phase: Placebo

OOL, Treatment Period: Lenvatinib 24 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: LenvatinibExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor

516 Previous Clinical Trials

159,003 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,287 Total Patients Enrolled

Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

7 Previous Clinical Trials

244 Total Patients Enrolled

Media Library

Adenoid Cystic Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT02780310 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are conducting this research?

"There are six listed clinical trial sites. Three of which are Memorial Sloan Kettering Cancer Centers located in Rockville Centre, New york and Middletown. The other three locations are..."

Answered by AI

Has the FDA given their blessing to Lenvatinib?

"Lenvatinib has received a score of 2 because, while there is evidence indicating that it is safe, we do not yet know if the medication works."

Answered by AI

How many individuals are being monitored as part of this research project?

"This particular trial is not currently recruiting patients. The 5/19/2016 post date and 6/1/2022 update on clinicaltrials.gov are the most recent information available. For other trials, there are 2555 studies for carcinoma, adenoid cystic and 155 Lenvatinib trials that are actively looking for participants."

Answered by AI

Do Lenvatinib's benefits outweigh its risks?

"Lenvatinib is currently being studied in 155 clinical trials, 32 of which are Phase 3. Although many of the studies for Lenvatinib originate from Iowa City, Iowa, there are 5027 locations researching this treatment option."

Answered by AI

Are there any vacancies in this experiment for new participants?

"No, this study is not presently seeking participants. Although the trial was posted on 5/19/2016 and edited as recently as 6/1/2022, according to clinicaltrials.gov, this particular research project is no longer recruiting patients. There are 2710 other trials that are still looking for candidates though."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

2016. "Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02780310.

All > Adenoid Cystic Carcinoma