Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04552769|
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Anaplastic Thyroid Cancer Undifferentiated Thyroid Cancer||Drug: Abemaciclib||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer|
|Actual Study Start Date :||September 10, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
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
200 mg orally
- Overall response (OR) [ Time Frame: 8 (+/-4) weeks from start of treatment ]
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
- Overall survival (OS) [ Time Frame: 3 years ]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
- Progression-free survival (PFS) [ Time Frame: 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552769
|Contact: Dhayoung (Michelle) Junfirstname.lastname@example.org|
|Principal Investigator:||Saad A Khan, MD||Stanford Universiy|