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Kinase Inhibitor
Vemurafenib for Thyroid Cancer
Phase 2
Waitlist Available
Led By Maria E. Cabanillas, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >/= 18
Eastern Cooperative Oncology Group (ECOG) performance status </= 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
Study Summary
This trial will test vemurafenib's ability to target the BRAF gene mutation in people with PTC. Researchers will also look at the drug's safety and side effects.
Who is the study for?
Adults with advanced papillary thyroid cancer (PTC) that's inoperable may join this trial. They should have the BRAF V600E mutation, be new to MAPK pathway therapies, and have their major organs functioning well. Pregnant women, those with significant heart disease or untreated brain metastases, or recent chemotherapy/targeted therapy users are excluded.Check my eligibility
What is being tested?
The study tests vemurafenib's effects on PTC biomarkers before surgery (neoadjuvant). All participants receive vemurafenib; Group A and C continue post-surgery. The drug aims to block a gene mutation responsible for cancer growth.See study design
What are the potential side effects?
Vemurafenib can cause joint pain, rash, fatigue, hair loss, skin changes like sensitivity to sunlight or development of new skin lesions. It might also affect liver enzymes and lead to vision problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and do some daily activities.
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My thyroid cancer is advanced and needs surgery.
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My thyroid cancer has come back or stayed and needs surgery due to affected lymph nodes.
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I stopped any antiangiogenic therapy at least 14 days ago and haven't had MAPK targeting therapies.
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My cancer has the BRAF V600E mutation.
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My liver enzymes are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change in ERK (Extracellular-Signal-Regulated Kinase) Phosphorylation and Tumor Size
Secondary outcome measures
Objective Response Rate
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Vemurafenib - Group CExperimental Treatment1 Intervention
Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56, Vemurafenib 960 mg by mouth twice a day unless there is evidence of progressive disease on day 56 CT scan. Patients evaluated for resectability after each CT scan is performed. If scheduled for resection, patient continues vemurafenib until surgery and follows same treatment schema as patients in Groups A and B.
Group II: Vemurafenib - (Presurgery)Experimental Treatment3 Interventions
All Groups: Vemurafenib 960 mg by mouth 2 times a day for 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56 +/- 7 days).
Group III: Vemurafenib (Post Surgery) - Group AExperimental Treatment1 Intervention
Vemurafenib 960 mg by mouth two times a day 2 weeks post-surgery, or if patients have not sufficiently recovered at that point, as soon as their condition permits. Patients in Group A restaged 8 weeks after resuming drug. If patients in Group A demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until no longer benefitting from the drug.
Group IV: Post Surgery - Group BActive Control1 Intervention
Post Surgery - Group B: Patients discontinue vemurafenib after surgery but will be restaged with CT neck 8 weeks after surgery.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,490 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,007 Total Patients Enrolled
Maria E. Cabanillas, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood creatinine level is within a certain range.Your absolute neutrophil count is at least 1.0 x 10^9 per liter.Your hemoglobin level is higher than 9 mg/dL.Your platelet count is at least 100 billion per liter.I am 18 years old or older.I can swallow pills.I can take care of myself and do some daily activities.I have severe nausea, vomiting, or issues absorbing food due to bowel surgery.I have brain metastases that have not been treated.I haven't had chemotherapy or targeted therapy within the last 14 days or 5 half-lives, whichever is longer.I have a heart condition related to long QT syndrome or my heart's electrical activity is abnormal.I do not have serious heart disease or uncontrolled irregular heartbeats.My thyroid cancer is advanced and needs surgery.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a recent negative pregnancy test.I have not had surgery for my condition and haven't received MAPK pathway treatments.My thyroid cancer has come back or stayed and needs surgery due to affected lymph nodes.I stopped any antiangiogenic therapy at least 14 days ago and haven't had MAPK targeting therapies.My cancer has the BRAF V600E mutation.My thyroid cancer is mainly papillary and not anaplastic.My liver enzymes are within the required limits.Your bilirubin levels are not too high, unless you have Gilbert's syndrome.You have hepatitis B or C virus infection, unless cleared for treatment by viral hepatitis experts.
Research Study Groups:
This trial has the following groups:- Group 1: Vemurafenib - (Presurgery)
- Group 2: Vemurafenib (Post Surgery) - Group A
- Group 3: Post Surgery - Group B
- Group 4: Vemurafenib - Group C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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