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Tyrosine Kinase Inhibitor

Cabozantinib + Temozolomide for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Janet Yoon, 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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 6 and 12, then every 2 cycles up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

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%

ALANINE AMINOTRANSFERASE INCREASED

41%

Neutrophil Count Decreased

41%

ASPARTATE AMINOTRANSFERASE INCREASED

41%

VOMITING

41%

ANOREXIA

41%

NAUSEA

36%

HEADACHE

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

36%

PAIN IN EXTREMITY

36%

HYPERTENSION

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

PLATELET COUNT DECREASE

23%

HYPONATREMIA

23%

Decreased Platelet Count

23%

Platelet Count Decreased

23%

Skin Hypopigmentation

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

Rash Acneiform

14%

Pruritis

14%

Rash Maculopapular

14%

HYPOGLYCEMIA

14%

HYPERGLYCEMIA

14%

BILIRUBIN INCREASED

14%

ACNEIFORM RASH

14%

Cough

14%

Blood Bilirubin Increased

14%

DIZZINESS

14%

Skin And Subcutaneous Disorders - Other, Achromotricia

14%

CONSTIPATION

14%

Fever

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

LIPASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

Paresthesia

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

NASAL CONGESTION

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Muscle Weakness Lower Limb

Allergic Rhinitis

Hypotension

Hypertension

SERUM AMYLASE INCREASED

Investigations - Other, Eosinophilia

Sore Throat

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Gastrointestinal Disorders - Other, Dental Pain

Scalp Pain

Scalp Lesion

Neuropathy

Psychiatric Disorders - Other, Mood Swings

URINARY URGENCY

Sinus Tachycardia

Periodontal Disease

Peripheral Sensory Neuropathy

Myalgia

Tooth Infection

RASH

Peripheral Motor Neuropathy

Tachycardia

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

JOINT RANGE OF MOTION DECREASED

INSOMNIA

Gastrointestinal Disorders - Other, Buccal Cyst

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

HEMATURIA

Investigations - Other, International Normalized Ration Increased

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Joint Range Of Motion Decreased

Behaviour Disturbance

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

Infections And Infestations - Other, Gi Viral Infection

Stomach Pain

TENDONITIS

SKIN INFECTION

HYPOMAGNESEMIA

Muscle Weakness Upper Limb

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS

Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger

Surgical & Medical Procedures - Other, Dental Extractions

Skin And Subcutaneous Tissue Disorders- Other, Erythema

Infections And Infestations - Other, Covid-19

Investigations - Other, Increased Mean Corpuscular Volume

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)

Urine Discoloration

SPINAL CORD COMPRESSION

ANEMIA

PARONYCHIA

BRUISING

HYPOALBUMINEMIA

Ear And Labyrinth Disorders - Other, Impacted Cerumen

Ear Pain

Elevated Amylase

Facial Pain

Gastrointestinal Disorders - Other, Stomatitis

Hoarseness

Laryngitis

Leg Pain

Localized Edema

Lung Infection

Metabolism And Nutrition Disorders - Other, Decreased Oral Intake

Metabolism Other - Decreased Vitamin D

Metbolism And Nutrition Disorders - Other, Hyperchloremia

Mucositis Oral

100%

80%

60%

40%

20%

Study treatment Arm

Cohort B

Cohort A

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880

Cabozantinib

2020

Completed Phase 2

~1760