Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
ConditionKaposi Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational Cancer Institute (NCI)
About this trial
Background:
Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help.
Objective:
To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors.
Eligibility:
People ages 18 and older with KS.
Design:
Participants will be screened with some or all of the following:
Medical history
Physical exam
Blood and urine tests
Chest x-ray and/or computed tomography scans
Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ)
Medicine review
Heart function tests
KS lesion assessment
Skin sample from a KS lesion
Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants who stopped taking abemaciclib because it was no longer providing additional benefit may be able to restart abemaciclib again.
Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed.
Participants will have follow-up visits for up to 2 years after treatment ends.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have Kaposi sarcoma confirmed by the Laboratory of Pathology, NCI
All participants in Groups 1, 2a, or 2b or 4 should have at least five measurable cutaneous KS lesions per AIDS Clinical Trials Group Oncology Committee (ACTG) criteria with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion and/or evaluable disease per RECIST criteria.
Measurable disease by the criteria proposed by the AIDS Clinical Trials Group Oncology Committee.
Participants in Group 3 must have Stage T1 KS with at least five measurable cutaneous KS lesions per ACTG criteria and/or evaluable disease per RECIST criteria.
Disqualifiers
Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study.
Participants 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 enrollment.
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia or neuropathy.
Participants who are receiving any other investigational agents.
Trial design
Design model
Sequential
Treatments tested in this trial
Abemaciclib
DrugAn initial dose of 200 mg twice daily and at an MTD dose will be administered orally every day of each 28-day cycle.
Treatment groups
111 Participants
are divided into 5 treatment groupsGroup A: 1/Dose Determination/De-EscalationExperimental treatment 1 intervention
Group B: 2/Dose Expansion: Group 2aExperimental treatment 1 intervention
Group C: 3/Dose Expansion: Group 2bExperimental treatment 1 intervention
Group D: 4/Dose Expansion: Group 3Experimental treatment 1 intervention
Group E: 5/Re-treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
safety and tolerability of abemaciclib
The fraction of patients with toxicity noted at each dose level will be reported by grade and type of toxicity identified.
Time frame
28 days2
overall response rate
Percentage of patients with the best overall response of CR or PR to therapy
Time frame
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 yearsSecondary outcomes
1
Progression free survival
Duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first
Time frame
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 years2
duration of response
The time criteria are met for CR or PR (whichever is recorded first) until the first date that patient no longer qualifies as a PR
Time frame
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 years3
KS response to abemaciclib
Staging and response to abemaciclib for KS by the evaluation of number, size, nodularity, and color of lesions.
Time frame
every 3 cycles from cycle 2 until completion of therapy, then every 3 months for 6 months, then every 6 months for 2 years, then annually for 2 years4
Overall response rate following retreatment
Percentage of patients who achieve a PR or CR
Time frame
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov