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Tyrosine Kinase Inhibitor

Cabozantinib + Temozolomide for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Mark Agulnik, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have adequate organ and bone marrow function based on specified laboratory values
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
Must not have
Major surgery within 56 days before the first dose of study treatment
Inability to swallow tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 6 and 12, then every 2 cycles up to 5 years
Awards & highlights

Summary

This trial is studying how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma.

Who is the study for?
This trial is for patients with leiomyosarcoma or other soft tissue sarcomas that can't be surgically removed or have spread. Participants must have a certain level of white blood cells, no more than five prior chemo treatments, controlled brain metastases, and good organ function. They should not be pregnant and must agree to use contraception.Check my eligibility
What is being tested?
The study tests the combination of cabozantinib (an enzyme blocker) and temozolomide (a chemotherapy drug) on tumor growth in leiomyosarcoma or other soft tissue sarcomas. The goal is to see if this combo works better than either drug alone.See study design
What are the potential side effects?
Potential side effects include typical reactions from cancer drugs such as fatigue, nausea, risk of infection due to low blood cell counts, liver issues, and possibly heart problems like abnormal heartbeats.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organ and bone marrow functions are within normal ranges.
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I am using birth control or my partner is.
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I am not pregnant and can become pregnant.
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I have had up to 5 chemotherapy treatments for my recurrent or spreading cancer.
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I understand the study requirements and have signed the consent form.
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My diagnosis is an inoperable or metastatic leiomyosarcoma or another type of soft tissue sarcoma.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 56 days.
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I cannot swallow pills.
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I have previously been treated with cabozantinib or temozolomide.
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I am currently taking blood thinners.
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I do not have any severe ongoing illnesses like heart or stomach problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 6 and 12, then every 2 cycles up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 6 and 12, then every 2 cycles up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Clinical benefit rate (Cohort 1)
Incidence of adverse events
Median progression free rate
+3 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
PAIN IN EXTREMITY
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Skin Hypopigmentation
23%
Platelet Count Decreased
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
ORAL PAIN
9%
TUMOR PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Hypertension
5%
ANXIETY
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Sore Throat
5%
Peripheral Sensory Neuropathy
5%
Peripheral Motor Neuropathy
5%
SINUS BRADYCARDIA
5%
Investigations - Other, Eosinophilia
5%
Stomach Pain
5%
INSOMNIA
5%
HEMATURIA
5%
TENDONITIS
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
HYPERTHYROIDISM
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
RASH
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib, temozolomide)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,329 Total Patients Enrolled
42 Trials studying Leiomyosarcoma
3,100 Patients Enrolled for Leiomyosarcoma
City of Hope Medical CenterLead Sponsor
575 Previous Clinical Trials
1,922,634 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
54 Patients Enrolled for Leiomyosarcoma
Mark Agulnik, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04200443 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200443 — Phase 2
Leiomyosarcoma Research Study Groups: Treatment (cabozantinib, temozolomide)
Leiomyosarcoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04200443 — Phase 2
~13 spots leftby Jul 2025
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