Study of Abemaciclib in Dedifferentiated Liposarcoma (NCT02846987) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Abemaciclib in Dedifferentiated Liposarcoma
United States33 participantsStarted 2016-07
Plain-language summary
The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A diagnosis of dedifferentiated liposarcoma confirmed at MSKCC.
* Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable.
* All patients must have measurable disease as defined by RECIST 1.1. Patients must also have evidence of disease progression by RECIST 1.1 within 6 months of first dose of study drug.
* Any number of prior therapies (including none) is permitted. The last dose of systemic therapy (include targeted therapies) must have been given at least 2 4 weeks prior to initiation of therapy. Patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy.
* Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.
* Age ≥ 18 years.
* ECOG performance status 0 or 1
* Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
* Absolute neutrophil count ≥ 1.510\^9/L
* Hemoglobin ≥ 8.0 g/dL
* WBC ≥ 3.0 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Total bilirubin ≤ 1.5 x ULN except for patients with known Gilbert syndrome
* AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN
* Creatinine ≤ 1.5 x ULN or Creatinine Clearance \> 50 mL/min (calculated by Cockcroft-Gault method)
* Patients must not have current evidence of another malignancy that requires treatment.
* Women of child-bearing potential and men must agr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.