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Protein Kinase Inhibitor

dabrafenib for Thyroid Cancer

Phase 2

Waitlist Available

Led By Manisha Shah, MD

Research Sponsored by Manisha Shah

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks after completion of study treatment

Awards & highlights

Study Summary

This trial is studying whether two drugs, dabrafenib and trametinib, can help treat patients with recurrent thyroid cancer.

Eligible Conditions

Thyroid Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Heart rate

Secondary outcome measures

Number of patients with Adverse events of GSK2118436 (BRAFi) as a single agent and adverse events of GSK2118436 (BRAFi) and GSK1120212 (MEKi) in combination.

Overall survival

Portion of patients with progression-free survival (PFS)

+1 more

Side effects data

From 2016 Phase 2 trial • 12 Patients • NCT01928940

67%

Aspartate aminotransferase increased

67%

Pyrexia

67%

Oedema peripheral

50%

Neutropenia

50%

Stomatitis

33%

Arthralgia

33%

Nasopharyngitis

33%

Headache

33%

Hypophosphataemia

33%

Blood alkaline phosphatase increased

33%

Constipation

33%

Anaemia

17%

Platelet count decreased

17%

Mitral valve incompetence

17%

Leukopenia

17%

Blood glucose increased

17%

Deafness neurosensory

17%

Blood phosphorus decreased

17%

Blood albumin decreased

17%

Blood lactate dehydrogenase increased

17%

Blood pressure increased

17%

Ejection fraction decreased

17%

Glucose urine present

17%

White blood cell count decreased

17%

Nausea

17%

Vomiting

17%

Myalgia

17%

Pain in extremity

17%

Erythema

17%

Pneumonia bacterial

17%

Neuropathy peripheral

17%

Cough

17%

Thermal burn

17%

Diarrhoea

17%

Erythema nodosum

17%

Chills

17%

Retinal vascular disorder

17%

Bronchitis

17%

Retinal detachment

17%

Gingival bleeding

17%

Rhinitis allergic

17%

Dermatitis acneiform

17%

Lip dry

17%

Alanine aminotransferase increased

17%

Mechanical urticaria

17%

Skin fissures

17%

Malaise

17%

Uveitis

100%

80%

60%

40%

20%

Study treatment Arm

Phase II: GSK2118436 150 mg + GSK1120212 2 mg

Phase I: GSK2118436 150 mg + GSK1120212 2 mg

Trial Design

3Treatment groups

Experimental Treatment

Group I: Correlative StudiesExperimental Treatment3 Interventions

Tumor pharmacodynamics (PD) evaluation,BRAF mutation quantification in circulating plasma DNA,Tumor mutation screening/Mechanisms of Drug Resistance,Predictive Markers of Response (Archival Tumor Block),Pharmacokinetics(PK,Pharmacogenetics (PGx)

Group II: Arm B: GSK2118436 and GSK1120212Experimental Treatment3 Interventions

Patients receive dabrafenib orally twice a day and trametinib orally once a day on days 1-28.

Group III: Arm A: GSK2118436Experimental Treatment2 Interventions

Patients receive dabrafenib orally 2 twice a day on days 1-28. Patients with disease progression may cross over to arm II.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

trametinib

2012

Completed Phase 2

~200

dabrafenib

2016

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Manisha ShahLead Sponsor

2 Previous Clinical Trials

29 Total Patients Enrolled

Bhavana KondaLead Sponsor

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,582 Total Patients Enrolled

Frequently Asked Questions

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

Have any other research studies utilized dabrafenib?

"First studied at the University of Chicago Medical Center in 2012, dabrafenib has now been tested across 88 completed clinical trials. Currently 95 ongoing trials are taking place, with a majority based out of Columbus, Ohio."

Answered by AI

What is the geographical scope of this experimental endeavor?

"To partake in this study, enrolment is being offered at Ohio State University Medical Center in Columbus, Massachusetts General Hospital, Harvard Medical School in Boston and the University of California San Diego. Additionally, there are another 5 sites offering participation opportunities."

Answered by AI

Are there any recruitment opportunities for this trial currently?

"Unfortunately, this research trial is no longer recruiting. Initial posting was on November 7th 2012 and the last update occurred on 14th of November 2022. Should you need to explore other study opportunities, there are currently 227 clinical studies for adenocarcinoma or follicular which welcome enrollment and 95 trials with dabrafenib actively seeking participants."

Answered by AI

What is the current number of recruitments for this research project?

"At this juncture, the clinical trial is not seeking participants. The study was first made available on November 7th 2012 and was updated most recently on November 14th 2022. If you are searching for alternative trials, there are currently 227 studies actively looking for patients with adenocarcinoma follicular cancer and 95 trials needing volunteers to take dabrafenib."

Answered by AI

Has dabrafenib been sanctioned by the FDA?

"Since dabrafenib is currently being evaluated in Phase 2 trials and there is existing data to support its safety, our team rates it with a score of two."

Answered by AI

Recent research and studies

Journal of the National Comprehensive Cancer NetworkJournal

KRAS G12V Mutation in Acquired Resistance to Combined BRAF and MEK Inhibition in Papillary Thyroid Cancer

Owen, Dwight H., Bhavana Konda, Jennifer Sipos, Tom Liu, Amy Webb, Matthew D. Ringel, Cynthia D. Timmers, and Manisha H. Shah. 2019. “KRAS G12V Mutation in Acquired Resistance to Combined BRAF and MEK Inhibition in Papillary Thyroid Cancer”. Journal of the National Comprehensive Cancer Network. Harborside Press, LLC. doi:10.6004/jnccn.2019.7292.

clinicaltrials.govStudy

Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer

Bhavana Konda 2012. "Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01723202.

All > Thyroid Cancer > Thyroid