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| ID | Type | Description | Link |
|---|---|---|---|
| END0023 | Other Identifier | OnCore | |
| NCI-2020-07832 | Other Identifier | NCI Trial Identifier |
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The purpose of the study is to evaluate the efficacy of treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid
Primary Objective The primary objective is to determine the overall response rate after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer.
Secondary Objectives The secondary objectives are to describe the overall survival (OS) and progression-free survival (PFS) after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer.Safety assessments of AE's will also be analysed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib | Experimental | Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | 200 mg orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response (OR) | Overall response defined as either complete response or partial response assessed using RECIST v1.1 criteria. This measure will be reported as a number without dispersion. RECIST v1.1 criteria: Evaluation of Target Lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, no appearance of new lesions. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesion(s) Progressive Disease (PD): Appearance of one or more new lesions | 8 (+/-4) weeks from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival defined as duration of time from start of treatment to death from any cause. This will be reported as median survival time with interquartile range | 3 years |
| Progression-free Survival (PFS) |
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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.
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).
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.
The patient is able to swallow oral medications.
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
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.
Patient has the ability to understand and provide signed informed consent.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad A Khan, MD | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib | Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops Abemaciclib: 200 mg orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib | Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops Abemaciclib: 200 mg orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Overall Response (OR) | Overall response defined as either complete response or partial response assessed using RECIST v1.1 criteria. This measure will be reported as a number without dispersion. RECIST v1.1 criteria: Evaluation of Target Lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, no appearance of new lesions. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesion(s) Progressive Disease (PD): Appearance of one or more new lesions | Posted | Count of Participants | Participants | 8 (+/-4) weeks from start of treatment |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abemaciclib | Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops Abemaciclib: 200 mg orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saad A. Khan, MD | Stanford University | 650-498-6000 | saad.a.khan@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Aug 28, 2024 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D065646 | Thyroid Carcinoma, Anaplastic |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
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Progression-free survival (PFS) defined as the duration of time from start of treatment to time of progression or death from any cause. This will be reported as median time with interquartile range.
| 3 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival defined as duration of time from start of treatment to death from any cause. This will be reported as median survival time with interquartile range | Posted | Median | Inter-Quartile Range | days | 3 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) defined as the duration of time from start of treatment to time of progression or death from any cause. This will be reported as median time with interquartile range. | Posted | Median | Inter-Quartile Range | day | 3 years |
|
|
|
| 7 |
| 9 |
| 6 |
| 9 |
| 9 |
| 9 |
| Lung infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tracheal obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hallucinations | Psychiatric disorders | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nail Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Unilateral Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shortness og Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Pnuemonia | Psychiatric disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cyst NOS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Glucose High | Endocrine disorders | Systematic Assessment |
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| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| WBC decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| Foot Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Creatinine Increased | Renal and urinary disorders | Systematic Assessment |
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| BUN Increased | Renal and urinary disorders | Systematic Assessment |
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| Alkaline phosphatase increased | Blood and lymphatic system disorders | Systematic Assessment |
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| ALT increased | Gastrointestinal disorders | Systematic Assessment |
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| Stomach irritated feeling of | Gastrointestinal disorders | Systematic Assessment |
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| cramps of extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| UTI | Renal and urinary disorders | Systematic Assessment |
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| Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| Hoarness of voice | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Swallowing difficult | Gastrointestinal disorders | Systematic Assessment |
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| Breathing difficult | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hypokalemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Weight loss | General disorders | Systematic Assessment |
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| Hypermagnesemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Increased creatinine clearance | Renal and urinary disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| CD4 lymphocytes | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutrophil count abnormal | Blood and lymphatic system disorders | Systematic Assessment |
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| Platelet count low | Blood and lymphatic system disorders | Systematic Assessment |
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| Monocyte decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| RDW Increased | Blood and lymphatic system disorders | Systematic Assessment |
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| Glucose Increased | Endocrine disorders | Systematic Assessment |
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| Chlorides blood increased | Blood and lymphatic system disorders | Systematic Assessment |
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| Troponin increased | Cardiac disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Pressure Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |