Cabozantinib for Uterine Corpus Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Uterine Corpus Leiomyosarcoma+10 MoreCabozantinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Uterine Corpus Leiomyosarcoma
  • Metastatic Leiomyosarcoma
  • Metastatic Soft Tissue Sarcoma
  • Unresectable Leiomyosarcoma
  • Unresectable Soft Tissue Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: At weeks 6 and 12, then every 2 cycles up to 5 years

5 years
Subject-reported outcomes
Week 12
Progression-free survival (PFS)
Year 5
Clinical benefit rate (Cohort 1)
Presence of response (Cohort 1)
Year 5
Incidence of adverse events
Up to 2 years
Overall survival (OS) (Cohort 1)
Up to 5 years
Median progression free rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cohort 1 - Cabozantinib, Trastuzumab for HER2+
76%Fatigue
52%Aspartate aminotransferase increased
48%Constipation
38%Nausea
38%Diarrhea
38%Headache
33%Mucositis oral
33%Hypertension
33%Palmar-plantar erythrodysesthesia syndrome
29%Alanine aminotransferase increased
24%Musculoskeletal and connective tissue disorder - Other, specify
19%Vomiting
19%Pain in extremity
19%Ataxia
19%Dizziness
19%Cough
19%Skin and subcutaneous tissue disorders - Other, specify
19%Anorexia
19%Serum amylase increased
14%Eye disorders - Other, specify
14%Flatulence
14%Pain
14%Hyponatremia
14%Rash maculo-papular
14%Insomnia
14%Lipase increased
14%Blood and lymphatic system disorders - Other, specify
14%Dysarthria
14%Hypothyroidism
14%Blurred vision
14%Abdominal pain
14%Dysgeusia
10%Tremor
10%Gait disturbance
10%Platelet count decreased
10%Investigations - Other, specify
10%Hyperglycemia
10%Generalized muscle weakness
10%Peripheral sensory neuropathy
10%Voice alteration
10%Alopecia
10%Rash acneiform
10%Gastrointestinal disorders - Other, specify
10%General disorders and administration site conditions - Other, specify
10%Weight loss
10%Back pain
10%Muscle weakness lower limb
10%Tracheal fistula
10%Ejection fraction decreased
10%Pancreatitis
10%Gastroesophageal reflux disease
10%Stomach pain
5%Dry eye
5%Dyspnea
5%Vascular disorders - Other, specify
5%Hot flashes
5%Thromboembolic event
5%Productive cough
5%Palpitations
5%Colitis
5%Duodenal hemorrhage
5%Eye infection
5%Skin infection
5%Vaginal infection
5%Bruising
5%Injury, poisoning and procedural complications - Other, specify
5%Blood bilirubin increased
5%Hypoglycemia
5%Muscle weakness upper limb
5%Myalgia
5%Neck pain
5%Cognitive disturbance
5%Nervous system disorders - Other, specify
5%Depression
5%Urinary incontinence
5%Dry skin
5%Anemia
5%Dysmenorrhea
5%Dehydration
5%Hypomagnesemia
5%Arthralgia
5%Confusion
5%Epistaxis
5%Papulopustular rash
5%Upper respiratory infection
5%Hearing impaired
5%Vertigo
5%Ear pain
5%Bloating
5%Seizure
5%Urinary urgency
5%Toothache
5%Dry mouth
5%Edema trunk
5%Dysphagia
5%Activated partial thromboplastin time prolonged
5%Hemorrhoids
5%Urinary tract infection
5%Sinus pain
5%Facial nerve disorder
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 1 - Cabozantinib, Trastuzumab for HER2+ ARM group. Side effects include: Fatigue with 76%, Aspartate aminotransferase increased with 52%, Constipation with 48%, Nausea with 38%, Diarrhea with 38%.

Trial Design

1 Treatment Group

Treatment (cabozantinib, temozolomide)
1 of 1

Experimental Treatment

72 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · Phase 2

Treatment (cabozantinib, temozolomide)Experimental Group · 4 Interventions: Temozolomide, Questionnaire Administration, Cabozantinib, Quality-of-Life Assessment · Intervention Types: Drug, Other, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at weeks 6 and 12, then every 2 cycles up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,100 Previous Clinical Trials
41,145,660 Total Patients Enrolled
11 Trials studying Uterine Corpus Leiomyosarcoma
743 Patients Enrolled for Uterine Corpus Leiomyosarcoma
City of Hope Medical CenterLead Sponsor
517 Previous Clinical Trials
2,249,499 Total Patients Enrolled
Mark Agulnik, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
90 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an absolute neutrophil count (ANC) of 1,500/mm^3 or more (>= 1.
Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Subjects with 0 - 5 prior chemotherapy regimens for recurrent/metastatic disease are eligible
Subjects with prior NGS reports completed on their tumor specimen will have this data collected.
You have a white blood cell count of at least 2500/mm^3 (>= 2.5 GI/L).
Hemoglobin > 90 g/L (>= 9 g/dL).