BridgeMD
New treatment option for Retroperitoneal Sarcoma
Official title A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
ClinicalTrials.gov ID: NCT06025747
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 retroperitoneal sarcoma.
Also referred to as LY-2835219, LY2835219.
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 phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
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
- people, \>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in...
- people must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT...
- At the time of study enrollment, people must have a tumor burden that is judged to be surgically resectable
- Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for people receiving...
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (\>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 14 days (people may...
You likely can't join if
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis
- Receipt of any prior radiation therapy for any reason to the affected area
- Known central nervous system (CNS) metastases
- Evidence of distant metastatic disease at time of treatment initiation
- History of thromboembolic event within 1 year of treatment initiation. Thromboembolic events include, but are not limited to, deep vein thrombosis...
- History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not...
See the full eligibility criteria
Who can join
- people, \>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in situ hybridization (FISH), or other clinically appropriate methodology...
- people must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT scan or MRI
- At the time of study enrollment, people must have a tumor burden that is judged to be surgically resectable
- Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for people receiving radiotherapy locally/at an outside institution must be reviewed and...
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (\>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 14 days (people may not have received blood product transfusion or granulocyte...
- White blood cell count \>= 2500/mm\^3 (\>= 2.5 GI/L) (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Platelets \>= 100,000/mm\^3 (\>= 100 GI/L) (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Hemoglobin \>= 8 g/dL (\>= 80 g/L) (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (people with Gilbert's disease =\< 2 x ULN and direct bilirubin within normal limits are permitted) (people may not have received blood product transfusion or G-CSF...
- Serum albumin \>= 2.8 g/dl (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Serum creatinine =\ = 30 mL/min (\>= 0.5 mL/sec) using the Cockcroft-Gault equation (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Urine protein/creatinine ratio (UPCR) =\< 1 mg/mg (=\< 113.2 mg/mmol) (people may not have received blood product transfusion or G-CSF within 14 days prior to screening)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male or non-pregnant and non-breast feeding female:
- Women of child-bearing potential (WOCBP) must agree to use highly effective contraception without interruption from initiation of therapy and continue until 4 months (120 days) after last dose of study therapy. WOCBP...
- Male people must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study
- Life expectancy of \> 3 months, as determined by the investigator
- Ability to understand and sign informed consent
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
What rules you out
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis
- Receipt of any prior radiation therapy for any reason to the affected area
- Known central nervous system (CNS) metastases
- Evidence of distant metastatic disease at time of treatment initiation
- History of thromboembolic event within 1 year of treatment initiation. Thromboembolic events include, but are not limited to, deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus...
- History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or...
- History of any major surgery within 14 days prior to enrollment
- Receipt of ongoing anti-coagulation for treatment or prophylaxis of thromboembolic event in the setting of prior thromboembolic event
- History of interstitial lung disease
- people with serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at...
- Pregnant or lactating females
- Inability to swallow tablets
- Previously identified allergy or hypersensitivity to components of the study treatment formulations
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized tumors deemed cured and not treated with systemic therapy
- Concurrent use of medications (especially those interacting with CYP3A) that potentially interact unsafely with abemaciclib which cannot be discontinued or substituted
- Recent infection requiring systemic anti-infective treatment that was completed =\< 14 days prior to enrollment (except for uncomplicated urinary tract infection or upper respiratory tract infection). Any active...
- Concurrent enrollment in any other type of medical research (for example: medical device) judged by the investigator not to be scientifically or medically compatible with this study
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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 Seattle, Washington, 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.