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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

Must not have

Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption

Untreated brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nausea, vomiting, or issues absorbing food due to bowel surgery.

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I have brain metastases that have not been treated.

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I have a heart condition related to long QT syndrome or my heart's electrical activity is abnormal.

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I do not have serious heart disease or uncontrolled irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change in ERK (Extracellular-Signal-Regulated Kinase) Phosphorylation and Tumor Size

Secondary study objectives

Objective Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met