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Protein Kinase Inhibitor

Dabrafenib + Lapatinib for Thyroid Cancer

Q: For what condition is Lapatinib typically prescribed?

<p>Lapatinib is commonly used to treat metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and has also been successfully utilized for treating <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> in postmenopausal patients.</p>

Phase 1

Waitlist Available

Led By Eric J Sherman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Fludeoxyglucose F 18 (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= 3) on a FDG-positron emission tomography (PET) scan

Absent or insufficient radioactive iodine uptake in either all lesions or an index lesion which has never been resected or received external beam radiation therapy as documented on a radioactive iodine scan (insufficient uptake must be confirmed by either an endocrinologist or nuclear medicine physician)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 7 of cycle 1

Awards & highlights

Study Summary

This trial is testing the combination of dabrafenib and lapatinib to treat patients with thyroid cancer that has not responded to previous treatment.

Who is the study for?

This trial is for patients with thyroid cancer that's spread or can't be removed by surgery, and hasn't improved after standard treatments. Participants must have a specific BRAF V600E or V600K mutation in their tumor, good organ function, no recent cancer treatments, and an ability to swallow pills. Women who can have children need to use non-hormonal birth control during the study.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Dabrafenib and Lapatinib. These drugs are believed to block enzymes important for cancer cell growth. The study aims to find the best dose with acceptable side effects for patients whose thyroid cancer has not been controlled by other treatments.See study design

What are the potential side effects?

Potential side effects include but are not limited to diarrhea, rash, fatigue, nausea and vomiting. There may also be liver issues like increased enzymes in blood tests or heart problems such as decreased heart function.

Eligibility Criteria

Inclusion Criteria

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

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My PET scan shows a highly active lesion with an SUVmax of 3 or more.

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My cancer does not absorb radioactive iodine well, as confirmed by a specialist.

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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.

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I am mostly active and can care for myself.

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I can take pills and don't have major gut issues affecting drug absorption.

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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.

Select...

My platelet count is at least 100,000 per microliter of blood.

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My liver tests are within the normal range required by the study.

Select...

I am mostly able to care for myself and carry out daily activities.

Select...

I have received more than 600 mCi of radioactive iodine in my lifetime.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 7 of cycle 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 7 of cycle 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 7 of cycle 1 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose (MTD) of lapatinib, in combination with the established dose of dabrafenib

Secondary outcome measures

Body tissue

Mean percentage change in transcript levels in the post-treatment tissues relative to pre-treatment tissues for several genes analyzed by reverse-transcriptase-polymerase chain reaction

Side effects data

From 2018 Phase 3 trial • 1286 Patients • NCT00073528

60%

Diarrhoea

34%

Rash

29%

Nausea

19%

Fatigue

17%

Arthralgia

15%

Back pain

15%

Vomiting

13%

Headache

13%

Dry skin

12%

Decreased appetite

12%

Pruritus

12%

Asthenia

11%

Alopecia

11%

Cough

10%

Pain in extremity

10%

Hot flush

10%

Nail disorder

Epistaxis

Dyspnoea

Alanine aminotransferase increased

Dyspepsia

Anaemia

Musculoskeletal pain

Aspartate aminotransferase increased

Nasopharyngitis

Dizziness

Constipation

Abdominal pain

Pyrexia

Paronychia

Abdominal pain upper

Mucosal inflammation

Acne

Insomnia

Musculoskeletal chest pain

Weight decreased

Muscle spasms

Stomatitis

Upper respiratory tract infection

Urinary tract infection

Blood alkaline phosphatase increased

Erythema

Bone pain

Myalgia

Oedema peripheral

Ejection fraction decreased

Left ventricular dysfunction

Erysipelas

Dehydration

Chest pain

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Letrozole 2.5 mg

Lapatinib 1500 mg + Letrozole 2.5 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lapatinib, dabrafenib)Experimental Treatment4 Interventions

Patients receive dabrafenib* PO BID on days 1-28 and lapatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients also receive dabrafenib PO for 2 weeks prior to beginning treatment with lapatinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lapatinib

2006

Completed Phase 3

~3530

Lapatinib Ditosylate

2006

Completed Phase 3

~580

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Dabrafenib

2011

Completed Phase 3

~4120

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,132 Total Patients Enrolled

Eric J ShermanPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

123 Total Patients Enrolled

Frequently Asked Questions

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

Has Lapatinib been granted permission from the FDA for clinical use?

"The safety of Lapatinib is tentatively assumed to be a 1, given that this is an initial Phase 1 trial with limited evidence regarding its efficacy and potential harm."

Answered by AI

What is the current capacity of this research project?

"This clinical trial is no longer recruiting, having first been posted on August 29th 2013 and last updated on August 11th 2022. Those who are seeking other medical studies can explore the 2,652 active trials for thyroid adenoma as well as 66 Lapatinib-related investigations actively searching for volunteers."

Answered by AI

Is there room for more participants in this clinical trial?

"Regrettably, this trial is not accepting new candidates at the moment. Originally put up on August 29th 2013 and revised just a few weeks ago (August 11th 2022), it may be worth looking into alternative trials; there are 2652 studies with patients seeking treatment for thyroid adenoma and 66 medical centres recruiting participants for Lapatinib therapies."

Answered by AI

Have there been prior experiments with Lapatinib?

"Presently, there are 66 Lapatinib trials that have been established across 5060 sites. Of these studies, 13 of them have reached Phase 3. Out of those locations in which research is being conducted the majority can be found in Lexington Kentucky."

Answered by AI

For what condition is Lapatinib typically prescribed?

"Lapatinib is commonly used to treat metastatic melanoma, and has also been successfully utilized for treating breast cancer in postmenopausal patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

2013. "Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01947023.

All > Basal Cell Carcinoma > Tykerb