What side effects are associated with this type of intervention?

Common treatments for Germ Cell Tumors (GCTs) include chemotherapy, radiation therapy, and targeted therapies such as Tyrosine Kinase Inhibitors (TKIs). Cabozantinib, a TKI being studied for refractory GCTs, has known side effects including hypertension, fatigue, diarrhea, hand-foot syndrome, and liver enzyme abnormalities. Other TKIs used in cancer treatment may also cause similar side effects, along with nausea, vomiting, and decreased appetite. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

Historically, the treatment of Germ Cell Tumors (GCTs) has primarily involved chemotherapy regimens such as cisplatin, etoposide, and bleomycin. While there are no specific FDA approvals for Tyrosine Kinase Inhibitors (TKIs) like Cabozantinib in the treatment of GCTs, TKIs have been explored in clinical trials for various refractory cancers. Cabozantinib itself is being studied for its potential in treating refractory GCTs, as it targets multiple pathways involved in tumor growth and angiogenesis.

What other types of research exist?

Promising novel alternatives to Cabozantinib for Germ Cell Tumors patients may include immunotherapy agents such as pembrolizumab and nivolumab, as well as other targeted therapies like sunitinib and sorafenib. Participation in clinical trials investigating new molecularly targeted agents or combination therapies could also be considered.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of the treatment until time of death or last follow up visit (up to 2 years)

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%

Neutrophil Count Decreased

41%

ALANINE AMINOTRANSFERASE INCREASED

41%

ASPARTATE AMINOTRANSFERASE INCREASED

41%

VOMITING

41%

ANOREXIA

41%

NAUSEA

36%

HYPERTENSION

36%

HEADACHE

36%

PAIN IN EXTREMITY

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

Decreased Platelet Count

23%

PLATELET COUNT DECREASE

23%

HYPONATREMIA

23%

Platelet Count Decreased

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

Skin Hypopigmentation

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

HYPERGLYCEMIA

14%

Skin And Subcutaneous Disorders - Other, Achromotricia

14%

Pruritis

14%

HYPOGLYCEMIA

14%

Rash Acneiform

14%

Rash Maculopapular

14%

BILIRUBIN INCREASED

14%

ACNEIFORM RASH

14%

Cough

14%

Blood Bilirubin Increased

14%

DIZZINESS

14%

CONSTIPATION

14%

Fever

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

NASAL CONGESTION

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

LIPASE INCREASED

Paresthesia

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

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

Hypotension

Joint Range Of Motion Decreased

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

Hypertension

SERUM AMYLASE INCREASED

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Muscle Weakness Upper Limb

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Skin And Subcutaneous Tissue Disorders- Other, Erythema

Investigations - Other, Eosinophilia

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Behaviour Disturbance

Scalp Pain

Psychiatric Disorders - Other, Mood Swings

Sinus Tachycardia

Periodontal Disease

Myalgia

Tooth Infection

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

JOINT RANGE OF MOTION DECREASED

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

Peripheral Motor Neuropathy

Scalp Lesion

Sore Throat

Tachycardia

INSOMNIA

URINARY URGENCY

Allergic Rhinitis

Peripheral Sensory Neuropathy

HEMATURIA

RASH

Infections And Infestations - Other, Covid-19

Gastrointestinal Disorders - Other, Buccal Cyst

Investigations - Other, International Normalized Ration Increased

Infections And Infestations - Other, Gi Viral Infection

Gastrointestinal Disorders - Other, Dental Pain

Stomach Pain

SKIN INFECTION

HYPOMAGNESEMIA

Surgical & Medical Procedures - Other, Dental Extractions

Neuropathy

Investigations - Other, Increased Mean Corpuscular Volume

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

TENDONITIS

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

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

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

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

Muscle Weakness Lower Limb

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: 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

~2360

0 / 23Eligibility criteria met

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

121 Previous Clinical Trials

20,108 Total Patients Enrolled

Nabil AdraLead Sponsor

4 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Germ Cell Tumors

18 Patients Enrolled for Germ Cell Tumors

Jennifer KingLead Sponsor

Junnifer King, MDPrincipal InvestigatorIndiana University

Nabil Adra, MD5.01 ReviewsPrincipal Investigator - Indiana University

Indiana University

4 Previous Clinical Trials

144 Total Patients Enrolled

5Patient Review

Dr. Adra came highly recommended to us by my Dad's urologist, Dr. Bihrle. We were very pleased with him from the start. He is very attentive and respectful to my Dad, and he takes the time to listen to our concerns as a family. We trust his treatment 110%. Cancer is a terrible disease and very scary. Dr. Adra has eased all of this tremendously for us!

Jennifer King, MDPrincipal InvestigatorIndiana University