A Phase 2 interventional study of Cabozantinib and Quality-of-Life Assessment in Metastatic Leiomyosarcoma, Metastatic Soft Tissue Sarcoma and Stage III Uterine Corpus Leiomyosarcoma AJCC v8, sponsored by City of Hope Medical Center. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib and temozolomide may work better than either one alone in treating patients with leiomyosarcoma or other soft tissue sarcoma. Cabozantinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public for the indication under investigation in this study.
PRIMARY OBJECTIVE:
I. To determine the progression-free survival (defined as complete response [CR]+partial response [PR]+stable disease [SD]) assessed at 12 weeks for subjects in Cohort 1 (Leiomyosarcoma Arm) treated with cabozantinib and temozolomide as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (defined as CR+PR) for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
II. To determine the clinical benefit rate (CR+PR+SD) for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
III. To evaluate the median progression free rate for subjects with combination of cabozantinib and temozolomide.
IV. To evaluate overall survival for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
V. To assess safety and tolerability for subjects treated with a combination of cabozantinib and temozolomide.
VI. To determine the overall response rate (defined as CR+PR) in Cohort 2 (other soft tissue sarcomas).
VII. To assess Quality of Life (QoL) and subject-reported outcomes as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the EuroQoL-Group Health Questionnaire (EQ-5D-5L).
EXPLORATORY OBJECTIVE:
I. To estimate the correlation of progression free rate (PFR) and overall survival (OS) to levels of sVEGFR2, PIGF, VEGF, HGF, sMET, VEGF-C, VEGF-D, and soluble AXL.
OUTLINE:
Patients receive cabozantinib orally (PO) once daily (QD) on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with progressive disease (PD) are followed up every 6 months for up to 2 years and patients without PD are followed up every 6 months for up to 5 years.
177 studies on the registry are indexed under Leiomyosarcoma; 35 are open to participants now.
This study's enrollment of 96 is above the median of 54 across 151 interventional studies indexed under Leiomyosarcoma.
Browse Leiomyosarcoma studies →City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must have a confirmed diagnosis of unresectable or :
Exclusion Criteria:
Receipt of any of the following:
Systemic treatment with radionuclides within 42 days before the first dose of study treatment
Major surgery (e.g., GI surgery, removal or of ) within 56 days before the first dose of study treatment
interval calculated by the Bazetts formula (QTcF) > 500 ms per (ECG) within 28 days before first dose of study treatment
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the first dose
Other clinically significant disorders that would preclude safe study participation
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and factor Xa inhibitors) or inhibitors (e.g., clopidogrel). is considered to be 5 half-lives of the drug. Allowed anticoagulants are the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive cabozantinib PO QD on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Drug: Temozolomide
Given PO
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Given PO
Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Progression-free Survival (PFS)
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS will be the time from the start of treatment to the time of progression, unequivocal clinical deterioration, or death from any cause. The proportion of patients who had a PFS event was calculated.
Time frame: After the first 12 weeks of therapy
Presence of Response
Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions. Overall Response (OR) = CR + PR. Defined as patients who reached an objective tumour response (eg, partial or complete response) according to RECIST by cycle four.
Time frame: At weeks 6 and 12, then every 2 cycles up to 5 years
Clinical Benefit Rate
Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; For non-target lesions, CR: Disappearance of all non-target lesions. Stable Disease (SD), Persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. Clinical Benefit = CR + PR + SD. Defined as the number of patients with complete, partial response, or stable disease.
Time frame: At weeks 6 and 12, then every 2 cycles up to 5 years
Median Progression Free Survival
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Will assess the time from the first dose of study treatment until progression based upon changes in RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
Time frame: Up to 5 years
Overall Survival (OS)
Will assess the time from the first dose of the study treatment until death from any cause, up to a maximum follow-up of two years.
Time frame: Up to 2 years
Number of Participants With Adverse Events
Will assess the presence of all toxicities outlined in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From time of first treatment up to the end of last treatment, up to 5 years
Subject-reported Outcomes
Will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) symptom score. The QLQ-C30 questionnaire is made up of 30 questions and contains five functional scales (physical, role, emotional, cognitive, and social functioning), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, and financial impact). The questionnaire uses a four-point response scale ("not at all", "a little", "quite a bit", and "very much"), with the exception of the global QoL scale, which has a seven-point response format. The scores were linearly transformed to a score between 0 and 100. For the functioning and the global QoL scales, a higher score indicates better health. For the symptoms scales, a higher score indicates more symptom burden. Linearly transformed scores for the nausea and vomiting item are reported here.
Time frame: Outcomes are measured at Cycle 1 to Cycle 4 between responders and non-responders
Between January 2020 and February 2023, 96 patients were assessed for eligibility, 24 were ineligible, and 72 were enrolled and included in the final analysis.
| Milestone | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Started | 42 | 30 |
| Completed | 42 | 30 |
| Not completed | 0 | 0 |
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS will be the time from the start of treatment to the time of progression, unequivocal clinical deterioration, or death from any cause. The proportion of patients who had a PFS event was calculated.
| Participants | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Progression-free Survival (PFS) | 33 | 29 |
Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions. Overall Response (OR) = CR + PR. Defined as patients who reached an objective tumour response (eg, partial or complete response) according to RECIST by cycle four.
| Participants | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Presence of Response | 7 | 2 |
Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; For non-target lesions, CR: Disappearance of all non-target lesions. Stable Disease (SD), Persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. Clinical Benefit = CR + PR + SD. Defined as the number of patients with complete, partial response, or stable disease.
| Participants | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Clinical Benefit Rate | 27 | 13 |
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Will assess the time from the first dose of study treatment until progression based upon changes in RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
| months | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Median Progression Free Survival | 6.3 (4.6 to 7.0) | 3.0 (1.4 to 4.6) |
Will assess the time from the first dose of the study treatment until death from any cause, up to a maximum follow-up of two years.
| months | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Overall Survival (OS) | 19.2 (11.4 to NA) | 7.7 (4.8 to 10.9) |
Will assess the presence of all toxicities outlined in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
| Participants | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Number of Participants With Adverse Events | 41 | 30 |
Will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) symptom score. The QLQ-C30 questionnaire is made up of 30 questions and contains five functional scales (physical, role, emotional, cognitive, and social functioning), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, and financial impact). The questionnaire uses a four-point response scale ("not at all", "a little", "quite a bit", and "very much"), with the exception of the global QoL scale, which has a seven-point response format. The scores were linearly transformed to a score between 0 and 100. For the functioning and the global QoL scales, a higher score indicates better health. For the symptoms scales, a higher score indicates more symptom burden. Linearly transformed scores for the nausea and vomiting item are reported here.
| score on a scale | Responders | Non-responders |
|---|---|---|
| Cycle 1 | 5.8 (0 to 15.9) | 7.1 (3.5 to 10.8) |
| Cycle 2 | 5.6 (0 to 15.8) | 12.9 (8.8 to 17.0) |
| Cycle 3 | 7.4 (0 to 19.0) | 15.9 (10.5 to 21.2) |
| Cycle 4 | 14.8 (1.2 to 28.4) | 19.7 (13.3 to 26.1) |
Collected over Adverse events were assessed from the time of initial treatment up to the end of last treatment, up to 5 years. All-Cause Mortality was assessed from start of treatment to time of death, up to 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | 25/42 (59.5%) | 9/42 (21.4%) | 42/42 (100%) |
| Cohort 2 - Patients With Other Soft Tissue Sarcomas | 26/30 (86.7%) | 11/30 (36.7%) | 29/30 (96.7%) |
| Event | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/42 | 2/30 |
| Disease progressionGeneral disorders and administration site conditions | 2/42 | 1/30 |
| Myocardial infarctionCardiac disorders | 0/42 | 1/30 |
| Abdominal painGastrointestinal disorders | 0/42 | 1/30 |
| DiarrheaGastrointestinal disorders | 0/42 | 1/30 |
| Death NOSGeneral disorders and administration site conditions | 0/42 | 1/30 |
| HyponatremiaMetabolism and nutrition disorders | 0/42 | 1/30 |
| SyncopeNervous system disorders | 1/42 | 1/30 |
| altered mental statusNervous system disorders | 0/42 | 1/30 |
| HematuriaRenal and urinary disorders | 0/42 | 1/30 |
| Event | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas |
|---|---|---|
| Platelet count decreasedInvestigations | 30/42 | 24/30 |
| NauseaGastrointestinal disorders | 28/42 | 16/30 |
| DiarrheaGastrointestinal disorders | 25/42 | 18/30 |
| VomitingGastrointestinal disorders | 23/42 | 14/30 |
| FatigueGeneral disorders and administration site conditions | 22/42 | 15/30 |
| AnorexiaMetabolism and nutrition disorders | 14/42 | 14/30 |
| ConstipationGastrointestinal disorders | 16/42 | 13/30 |
| Neutrophil count decreasedInvestigations | 18/42 | 12/30 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 18/42 | 2/30 |
| HeadacheNervous system disorders | 17/42 | 5/30 |
| Age, Continuous(years) | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas | Total |
|---|---|---|---|
| Median | 59 (52 to 66) | 63 (50 to 69) | 60 (51 to 68) |
| Sex: Female, Male(Participants) | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas | Total |
|---|---|---|---|
| Female | 31 | 11 | 42 |
| Male | 11 | 19 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 36 | 25 | 61 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 34 | 26 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | Cohort 2 - Patients With Other Soft Tissue Sarcomas | Total |
|---|---|---|---|
| United States | 42 | 30 | 72 |
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Studies of the drugs tested here: Cabozantinib · Temozolomide