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CDK4/6 Inhibitor
Abemaciclib for Kaposi Sarcoma
Phase 1 & 2
Recruiting
Led By Ramya M Ramaswami, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For phase 1: Participants must have received at least 1 prior line of systemic therapy for KS with either plateau in response, progressive disease, or inadequate response to treatment. Previous local therapy or radiation is not considered systemic therapy
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Must not have
Pregnant persons are excluded from this study because abemaciclib is CDK inhibitor with the potential for teratogenic or abortifacient effects
No active KSHV-associated multicentric Castleman disease, KSHV-associated inflammatory cytokine syndrome or primary effusion lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 cycles until completion of therapy, then every 3 months for 6 months, then every 6 months for 2 years, then annually for 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a drug called abemaciclib to see if it can help treat people with Kaposi sarcoma.
Who is the study for?
Adults over 18 with Kaposi Sarcoma (KS), either HIV-positive on effective therapy or HIV-negative, can join. They must have tried at least one KS treatment without success for phase 1, or not received any systemic therapy for phase 2b. Participants need good organ and marrow function, no severe infections, controlled hepatitis if present, and agree to use contraception.
What is being tested?
The trial is testing Abemaciclib's safety and effectiveness in shrinking KS tumors. It involves taking the drug orally every day in cycles of 28 days until cancer progression or unacceptable side effects occur. The study includes regular health checks, lesion assessments, quality of life questionnaires, and follow-ups for up to two years post-treatment.
What are the potential side effects?
Abemaciclib may cause side effects such as fatigue; low white blood cell counts which can lead to infection risk; nausea; diarrhea; hair loss except alopecia or neuropathy that persists after other treatments; potential harm to a fetus so pregnant women are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Kaposi's sarcoma and my previous treatment didn’t work well.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
Your blood counts, liver function, and kidney function need to be within certain ranges. Your heart's pumping function also needs to be above a certain level.
Select...
I have at least 5 skin lesions from Kaposi's sarcoma that haven't been treated with radiation or surgery.
Select...
My Kaposi sarcoma diagnosis is confirmed by NCI's Pathology Lab.
Select...
I can care for myself but may not be able to do active work.
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I am older than 18 years.
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I do not have any severe infections that are not under control.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant.
Select...
I do not have active KSHV-related diseases.
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I have interstitial lung disease.
Select...
I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.
Select...
I am not taking any strong or moderate CYP3A4 inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 cycles until completion of therapy, then every 3 months for 6 months, then every 6 months for 2 years, then annually for 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 cycles until completion of therapy, then every 3 months for 6 months, then every 6 months for 2 years, then annually for 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
overall response rate
safety and tolerability of abemaciclib
Secondary study objectives
KS response to abemaciclib
Progression free survival
duration of response
Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 2/Dose Expansion: Group 2bExperimental Treatment1 Intervention
Abemaciclib (at optimal dose determined in dose escalation portion of the study) for up to 10 previously untreated participants.
Group II: 2/Dose Expansion: Group 2aExperimental Treatment1 Intervention
Abemaciclib (at optimal dose determined in dose escalation portion of the study) for up to 15 participants previously treated with at least 1 line of systemic therapy.
Group III: 1/Dose Determination/De-EscalationExperimental Treatment1 Intervention
Abemaciclib (de-escalating dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,943 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
592 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood counts, liver function, and kidney function need to be within certain ranges. Your heart's pumping function also needs to be above a certain level.I've been on ART for 8 weeks without KS improvement in the last 4 weeks.You have had serious allergic reactions to drugs similar to the CDK inhibitor.My heart is healthy enough for this trial, according to NYHA class 2B or better.I have recovered from side effects of previous cancer treatments, except for hair loss or nerve issues.I have Kaposi's sarcoma and my previous treatment didn’t work well.My hepatitis B virus load is undetectable with treatment.I have at least 5 skin lesions from Kaposi's sarcoma that haven't been treated with radiation or surgery.I can swallow pills.My Kaposi sarcoma diagnosis is confirmed by NCI's Pathology Lab.Your disease can be measured by specific criteria from the AIDS Clinical Trials Group Oncology Committee.My HIV status can be either positive or negative.I am not pregnant.I do not have active KSHV-related diseases.I have another cancer, but it won't affect this treatment's safety or results.I have interstitial lung disease.I can care for myself but may not be able to do active work.I am older than 18 years.I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.I haven't had chemotherapy or immunotherapy in the last 3 weeks.I am not taking any strong or moderate CYP3A4 inhibitors.I have Kaposi's sarcoma and haven't had systemic therapy for it.I have Kaposi's sarcoma and my previous treatment didn’t work well.I am HIV positive and on effective treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I do not have any severe infections that are not under control.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Dose Determination/De-Escalation
- Group 2: 2/Dose Expansion: Group 2a
- Group 3: 2/Dose Expansion: Group 2b
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