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Protein Kinase Inhibitor
Dabrafenib With or Without Trametinib in Treating Patients With Recurrent 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
No Placebo-Only Group
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heart rate
Secondary study objectives
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 moreSide effects data
From 2016 Phase 2 trial • 12 Patients • NCT0192894067%
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%
Leukopenia
17%
Mitral valve incompetence
17%
Deafness neurosensory
17%
Blood glucose increased
17%
Platelet count decreased
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%
0%
Study treatment Arm
Phase II: GSK2118436 150 mg + GSK1120212 2 mg
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2018
Completed Phase 2
~260
dabrafenib
2016
Completed Phase 2
~60
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
120 Previous Clinical Trials
7,347 Total Patients Enrolled
Manisha Shah, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
23 Total Patients Enrolled
Bhavana Konda, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center