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New treatment option for Chondrosarcoma
Official title Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
ClinicalTrials.gov ID: NCT04040205
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chondrosarcoma.
Also referred to as Verzenio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1. Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see
You likely can't join if
- below)
- Metastatic or locally advanced disease that is unresectable
- There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met:
- Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy
- Osteosarcoma (high-grade), Dedifferentiated chondrosarcoma: at least 1 prior anthracycline chemotherapy, alone or in combination, required either as...
- Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard...
See the full eligibility criteria
Who can join
- 1. Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see
What rules you out
- below)
- Metastatic or locally advanced disease that is unresectable
- There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met:
- Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy
- Osteosarcoma (high-grade), Dedifferentiated chondrosarcoma: at least 1 prior anthracycline chemotherapy, alone or in combination, required either as adjuvant, neoadjuvant or in the metastatic setting. If anthracycline...
- Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.
- Age ≥ 18 years.
- Provide study specific (step 1) informed consent prior to study entry
- Documented CDK pathway abnormality on a commercially available mutation profiling test (Foundation, Tempus xT, etc), if performed previously as part of routine/standard care on tumor (metastatic or primary), having at...
- Cyclin D1 (CCND1), cyclin D2 (CCND2), cyclin D3 (CCND3), cyclin dependent kinase 4 (CDK4), and/or cyclin dependent kinase 6 (CDK6) amplification/copy number gain
- Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) or CDKN2B copy number loss
- Provide study-specific (step 2) informed consent
- Rb positive confirmed by immunohistochemistry testing of archived tumor tissue specimen (metastatic or primary site) performed centrally at Medical College of Wisconsin Precision Medicine Laboratory.
- All people must have measurable disease as defined by RECIST 1.1. (See RECIST 1.1 criteria in Appendix 10.
- people must also have had evidence of disease progression by RECIST 1.1 within 6 months of enrollment, or newly diagnosed within the last 6 months (refer to step 1 criteria regarding previous lines of therapy).
- A washout period of at least 21 days is required between last chemotherapy dose and enrollment.
- A washout period of at least 14 days is required between end of radiotherapy and enrollment.
- At least 14 days after surgery, and absence of significant wound healing issues that would pose infection risk.
- people with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
- Hemoglobin ≥ 8.0 g/dL a. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte...
- Platelets ≥ 100 x 10\^9/L
- Total bilirubin ≤ 1.5 x ULN a. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
- Aspartate aminotransferase (AST)(SGOT)/alanine aminotransferase (ALT)(SGPT) ≤ 3 x institutional ULN
- Renal function (at least one of the following): Estimated Creatinine Clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault), estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m\^2 (MDRD or Chronic Kidney Disease...
- Female people must meet one of the following:
- Postmenopausal for at least one year before enrollment, OR
- Surgically sterile (i.e. undergone a hysterectomy or bilateral oophorectomy), OR
- If subject is of childbearing potential (defined as not satisfying either of the above two criteria), must have a negative serum pregnancy test within 21 days of step 2 enrollment AND
- Agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom...
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not...
- Male people, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:
- Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are...
- people must be deemed able to comply with the study plan by the local PI.
- Ability to swallow oral medications Exclusion Criteria:
- Diagnosis of well differentiated (WD) or dedifferentiated (DD) liposarcoma
- Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).
- people who have not recovered (Common Terminology Criteria for Adverse Events [CTCAE v5.0] Grade ≤1) from the acute effects of chemotherapy (except for residual alopecia or Grade 2 peripheral neuropathy) prior to...
- people currently receiving any other investigational agents.
- Current ongoing treatment with strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers or inhibitors.
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active bacterial infection (requiring IV antibiotics), fungal infection, detectable viral infection (such as known HIV or active...
- The subject has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and...
- Pregnant women and women who are breast-feeding.
- people must not have current evidence of another malignancy that requires treatment.
- people who received treatment with live attenuated viruses within 30 days prior to eligibility confirmation or might receive the treatment through the duration of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Iowa City, Iowa, United States
- St Louis, Missouri, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Iowa City, Iowa, United States; St Louis, Missouri, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.