Trial Outcomes & Findings for Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer (NCT NCT04552769)
NCT ID: NCT04552769
Last Updated: 2025-06-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
8 (+/-4) weeks from start of treatment
Results posted on
2025-06-05
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Abemaciclib
n=9 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 (+/-4) weeks from start of treatmentOverall 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
Outcome measures
| Measure |
Abemaciclib
n=9 Participants
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
|
|---|---|
|
Number of Participants With Overall Response (OR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 yearsOverall 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
Outcome measures
| Measure |
Abemaciclib
n=9 Participants
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
|
|---|---|
|
Overall Survival (OS)
|
130 days
Interval 56.0 to
The upper bound of the inter-quartile range was not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 3 yearsProgression-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.
Outcome measures
| Measure |
Abemaciclib
n=9 Participants
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
|
|---|---|
|
Progression-free Survival (PFS)
|
69 day
Interval 35.0 to 125.0
|
Adverse Events
Abemaciclib
Serious events: 6 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Abemaciclib
n=9 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
22.2%
2/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal obstruction
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
11.1%
1/9 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Abemaciclib
n=9 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 13 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 8 • 3 years
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
66.7%
6/9 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Vomitting
|
22.2%
2/9 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Unilateral Leg pain
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness og Breath
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Pnuemonia
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
22.2%
2/9 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Cyst NOS
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Endocrine disorders
Glucose High
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
WBC decreased
|
11.1%
1/9 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Foot Edema
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Creatinine Increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
BUN Increased
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
ALT increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Stomach irritated feeling of
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
cramps of extremities
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
UTI
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarness of voice
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Swallowing difficult
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficult
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
General disorders
Weight loss
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Increased creatinine clearance
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
CD4 lymphocytes
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophil count abnormal
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Platelet count low
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Monocyte decreased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
RDW Increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Endocrine disorders
Glucose Increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Chlorides blood increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Cardiac disorders
Troponin increased
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pressure Ulcer
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place