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CDK4/6 Inhibitor

Abemaciclib for Thyroid Cancer

Phase 2

Waitlist Available

Led By Saad A Khan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test whether abemaciclib can shrink tumors in patients with anaplastic thyroid cancer or undifferentiated thyroid cancer.

Who is the study for?

This trial is for adults with advanced anaplastic or undifferentiated thyroid cancer that can't be cured by surgery or radiation. Participants must have acceptable organ function, not be pregnant, and agree to use contraception. They should not have other serious medical conditions, a history of certain heart issues, or active infections.Check my eligibility

What is being tested?

The study tests the effectiveness of abemaciclib in treating advanced thyroid cancer. Patients will take this oral medication and their response to treatment will be monitored according to specific health criteria outlined in the study design.See study design

What are the potential side effects?

Abemaciclib may cause side effects such as diarrhea, fatigue, low blood cell counts which can increase infection risk, liver problems indicated by blood test changes, and potential harm to unborn babies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response (OR)

Secondary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Trial Design

1Treatment groups

Experimental Treatment

Group I: AbemaciclibExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,183 Total Patients Enrolled

Saad A Khan, MDPrincipal InvestigatorStanford Universiy

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this medical trial still underway?

"As of 11/8/2022, this clinical trial is not enrolling patients. Initially posted on 9/10/2020, the study has been inactive for a while now. For those still seeking to participate in medical research trials related to thyroid cancer and Abemaciclib, there are currently 233 active studies and 92 recruitment drives respectively."

Answered by AI

What potential risks are associated with Abemaciclib administration?

"After a thorough assessment, Abemaciclib was assigned a safety rating of 2. This is because there are some reports indicating the drug's safety but no evidence that it works as intended."

Answered by AI

Has this investigation been carried out before?

"Abemaciclib's introduction to clinical trials dates back to 2009, when it was sponsored by Eli Lilly and Company. This Phase 1 approved medication has since been tested in 92 studies across 1276 cities in 41 countries worldwide."

Answered by AI

What is the current enrollment size for this scientific experiment?

"This clinical trial is no longer accepting recruits, as the last update was made on November 8th, 2022. If you are searching for alternate research opportunities, 233 studies related to thyroid cancer and 92 studies linked to Abemaciclib may still be actively enrolling patients."

Answered by AI

What is the common application of Abemaciclib?

"Abemaciclib typically serves to mitigate the chances of relapse for high-risk patients. Additionally, it can also be used as an endocrine therapy option for advanced HR+ HER2- breast cancer and other related conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

2020. "Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04552769.

All > Anaplastic Ependymoma > Thyroid