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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%

Diarrhoea

69%

Hypertension

57%

Decreased appetite

54%

Weight decreased

49%

Nausea

44%

Fatigue

40%

Headache

38%

Proteinuria

38%

Vomiting

38%

Stomatitis

33%

Palmar-plantar erythrodysaesthesia syndrome

33%

Arthralgia

33%

Dysphonia

32%

Constipation

30%

Cough

26%

Asthenia

25%

Oedema peripheral

21%

Rash

20%

Back pain

20%

Myalgia

19%

Abdominal pain

18%

Pain in extremity

18%

Abdominal pain upper

18%

Musculoskeletal pain

18%

Dry mouth

18%

Dyspnoea

18%

Dysgeusia

17%

Dizziness

16%

Pyrexia

16%

Oropharyngeal pain

16%

Hypokalaemia

15%

Hypocalcaemia

15%

Dyspepsia

14%

Epistaxis

13%

Dysphagia

13%

Alopecia

12%

Anaemia

12%

Musculoskeletal chest pain

12%

Dry skin

11%

Urinary tract infection

11%

Nasopharyngitis

10%

Oral pain

10%

Thrombocytopenia

10%

Blood creatinine increased

10%

Electrocardiogram QT prolonged

10%

Hypoalbuminaemia

10%

Upper respiratory tract infection

Dehydration

Neck pain

Hypomagnesaemia

Influenza like illness

Muscle spasms

Depression

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Hyponatraemia

Ejection fraction decreased

Haematuria

Malaise

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Pruritus

Influenza

Anxiety

Flatulence

Hyperglycaemia

Leukopenia

Dysuria

Productive cough

Non-cardiac chest pain

Paraesthesia

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Cholecystitis

Sepsis

Pulmonary embolism

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Malignant pleural effusion

Spinal cord compression

Acute kidney injury

Acute coronary syndrome

Blood uric acid increased

Hypercalcaemia

Monoparesis

Intestinal obstruction

Death

Small intestinal obstruction

Osteoarthritis

Colitis

Transient ischaemic attack

Acute respiratory failure

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Hepatic failure

Liver injury

Diverticulitis

Appendicitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Intracranial tumour haemorrhage

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Respiratory failure

Nephrotic syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Randomization Phase: Lenvatinib 24 mg

OOL, Treatment Period: Lenvatinib 20 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

159,000 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,938 Previous Clinical Trials

588,342 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