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Tyrosine Kinase Inhibitor

Cabozantinib for Germ Cell Tumors

Phase 2
Recruiting
Led By Junnifer King, MD
Research Sponsored by Nabil Adra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
5.1. 'Failure' of prior therapy is defined as: 5.1.1. A >25% increase in the products of the perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection.
Subjects with relapsed primary mediastinal non-seminomatous germ cell tumor (PMNSGCT) are eligible
Must not have
Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
10.2 Gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of the treatment until time of death or last follow up visit (up to 2 years)
Awards & highlights

Summary

This trial is testing Cabozantinib, a drug that slows down or stops cancer cell growth. It is aimed at patients with germ cell tumors that do not respond to standard treatments. Cabozantinib works by blocking proteins that cancer cells need to grow.

Who is the study for?
This trial is for adults over 18 with incurable, refractory germ cell tumors who have already undergone first-line cisplatin chemotherapy and at least one salvage regimen without success. They should not be candidates for further curative treatments like surgery. Participants must have acceptable organ function and performance status, understand the study protocol, and agree to use contraception if of childbearing potential.
What is being tested?
The trial is testing Cabozantinib in patients with germ cell tumors that haven't responded to standard therapies. Treatment continues until disease progression or unacceptable side effects occur. The goal is to see how effective this drug is in controlling the disease when other treatments have failed.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Cabozantinib may include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome (redness and pain on palms and soles), high blood pressure, weight loss, vomiting, voice changes and taste alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer grew by more than 25% during my last treatment and cannot be removed with surgery.
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My cancer is a type of testicular cancer that has come back after treatment.
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My kidney function is within the required range and my protein levels in urine are low.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am able to get out of my bed or chair and move around.
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I have a confirmed germ cell tumor diagnosis.
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My cancer has worsened after initial and subsequent treatments, and is now considered incurable with standard methods.
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My cancer grew by more than 25% during my last treatment and cannot be removed with surgery.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not controlled even with medication.
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I do not have high-risk GI disorders.
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Rewritten Criteria: a. You have a serious wound or bone fracture that has not healed. b. You have untreated, noticeable symptoms of an underactive thyroid gland. c. You have moderate to severe liver problems.
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I have a tumor affecting my digestive system or a serious digestive condition.
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I haven't taken any kinase inhibitor medication in the last 2 weeks.
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I am not pregnant or breastfeeding.
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I haven't had a stroke, heart attack, or blood clot in the last 6 months.
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My cancer is growing into or around major blood vessels.
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I am not taking certain blood thinners but may be on approved ones.
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I have lung lesions or airway disease.
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I have been treated with Cabozantinib before.
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I cannot swallow pills.
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I have severe heart issues, including heart failure or unstable angina.
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I have not had significant bleeding, like coughing up or vomiting blood, in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of the treatment until time of death or last follow up visit (up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of the treatment until time of death or last follow up visit (up to 2 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
Clinical benefit rate
Secondary study objectives
Incidence of Adverse Events
Objective response rate
Overall survival
+1 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%
NAUSEA
41%
ANOREXIA
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%
Skin Hypopigmentation
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Platelet Count Decreased
23%
Decreased Platelet Count
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
Pruritis
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
CONSTIPATION
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
Rash Maculopapular
14%
Fever
9%
Papulopustular Rash
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ALKALINE PHOSPHATASE INCREASED
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
TUMOR PAIN
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Sore Throat
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Investigations - Other, Eosinophilia
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Rash Ezcematoid
5%
HYPOMAGNESEMIA
5%
Activated Partial Thromboplastin Time Prolonged
5%
Investigations - Other, International Normalized Ration Increased
5%
Myalgia
5%
Scalp Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Psychiatric Disorders - Other, Mood Swings
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
TENDONITIS
5%
INSOMNIA
5%
URINARY URGENCY
5%
Allergic Rhinitis
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%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Tachycardia
5%
Infections And Infestations - Other, Covid-19
5%
Peripheral Motor Neuropathy
5%
Tooth Infection
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
ANXIETY
5%
JOINT RANGE OF MOTION DECREASED
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Muscle Weakness Upper Limb
5%
Neuropathy
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Stomach Pain
5%
Syncope
5%
RASH
5%
HEMATURIA
5%
Breast Pain
5%
Joint Range Of Motion Decreased
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
SKIN INFECTION
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Germ Cell Tumors (GCTs) include chemotherapy agents like cisplatin, etoposide, and bleomycin, which work by damaging the DNA of cancer cells, leading to cell death. Cabozantinib, a Tyrosine Kinase Inhibitor (TKI), targets multiple tyrosine kinases involved in tumor growth and angiogenesis, such as MET, VEGFR, and AXL. This is particularly relevant for GCT patients with refractory disease, as TKIs like Cabozantinib offer a targeted approach that can inhibit pathways critical for tumor survival and proliferation, potentially overcoming resistance to conventional chemotherapy.
Management consideration in nonpulmonary visceral metastatic seminoma of testis.

Find a Location

Who is running the clinical trial?

ExelixisIndustry Sponsor
119 Previous Clinical Trials
19,869 Total Patients Enrolled
Nabil AdraLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
2 Trials studying Germ Cell Tumors
82 Patients Enrolled for Germ Cell Tumors
Jennifer KingLead Sponsor
~2 spots leftby Dec 2024
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