Trial Search Results

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Abemaciclib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. 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.

   2. Patients will be eligible if they meet either criteria:

      - Unresectable anaplastic thyroid cancer limited to the neck: Patients must have
      received radiation therapy or surgery to primary tumor and have subsequent
      evidence of anaplastic thyroid cancer (ATC).

      - Metastatic anaplastic thyroid cancer: either with entirely surgically removed
      cancer/metastatic only disease, or with disease in the neck not requiring
      radiation or surgery to the neck mass.

   3. 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

   4. Patients will not have any other curative therapeutic option, such as radiation or
   surgery.

   5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

   6. Have measurable disease based on RECIST 1.1

   7. 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.

   8. Be ≥ 18 years of age on day of signing informed consent.

   9. Patients who received chemotherapy must have recovered (Common Terminology Criteria
   for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for
   residual alopecia or Grade 2 peripheral neuropathy prior to study treatment start. A
   washout period of at least 21 days is required between last chemotherapy dose and
   study treatment start (provided the patient did not receive radiotherapy).

10. Patients who received radiotherapy must have completed and fully recovered from the
   acute effects of radiotherapy. A washout period of at least 14 days is required
   between end of radiotherapy and study treatment start.

11. The patient is able to swallow oral medications.

12. The patient has adequate organ function for all of the following criteria, Laboratory
   Value Guidance to Establish Adequate Organ Function System Laboratory Value
   Hematologic absolute neutrophil count (ANC)≥1.5 × 109/L Platelets≥100 × 109/L
   Hemoglobin≥8 g/dL Patients may receive erythrocyte transfusions to achieve this
   hemoglobin level at the discretion of the investigator. Initial treatment must not
   begin earlier than the day after the erythrocyte transfusion.

   Hepatic Total bilirubin ≤1.5 × upper limit of normal(ULN) Patients with Gilbert's
   syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal
   limits are permitted.

   alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3 × ULN

13. Women of childbearing potential and all men must agree to use adequate contraception
   (hormonal or barrier method of birth control; abstinence) while taking drug and agree
   to continue for 3 months after the last dose of study treatment. Women of child
   bearing potential and male patients for 3 months should not mother or father a child
   in this period. A condom is required to be used also by vasectomized men in order to
   prevent delivery of the drug via seminal fluid.

14. Patient has the ability to understand and provide signed informed consent.

15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
   tests and other procedures.

Exclusion Criteria:

   1. Patients with known hypersensitivity to any of the excipients of abemaciclib

   2. History of carcinomatous meningitis

   3. Prior therapy with abemaciclib.

   4. 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).

   5. Females who are pregnant or lactating.

   6. 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.

   7. 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.

   8. 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle D Jun
650-721-4079
Recruiting