CompletedPhase 2

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

United States9 participantsStarted 2020-09-10

Plain-language summary

The purpose of the study is to evaluate the efficacy of treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that does not have a known BRAF V600E positive on tissue/blood testing. BRAF V600E positive patients are eligible if they have previously received FDA approved therapy for this genetic abnormality and progressed or become intolerant.
✓. Patients will be eligible if they meet either criteria:
✓. Patients with a bulky thyroid/neck mass and those in whom airway obstruction is suspected should undergo an evaluation via indirect or direct laryngoscopy to ensure patency of the trachea/airway prior to enrollment
✓. Patients will not have any other curative therapeutic option, such as radiation or surgery.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Have measurable disease based on RECIST 1.1
✓. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived sample.
✓. Be ≥ 18 years of age on day of signing informed consent.

Exclusion criteria

✕. Patients with known hypersensitivity to any of the excipients of abemaciclib
✕. History of carcinomatous meningitis
✕. Prior therapy with abemaciclib.
✕. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
✕. Females who are pregnant or lactating.
✕. The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
✕. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
✕. Presence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.

What they're measuring

Number of Participants With Overall Response (OR)

Timeframe: 8 (+/-4) weeks from start of treatment

Trial details

NCT IDNCT04552769

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-12

Results submitted2024-06-07

View on ClinicalTrials.gov More Thyroid Cancer trials