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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
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

Study Summary

This trial will study whether the drug Cabozantinib can help patients with incurable germ cell tumors. Treatment will continue until the disease progresses, the patient can't tolerate the side effects, or the study ends.

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.Check my eligibility
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.See study design
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.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have a confirmed germ cell tumor diagnosis.
Select...
My cancer has worsened after initial and subsequent treatments, and is now considered incurable with standard methods.
Select...
My cancer grew by more than 25% during my last treatment and cannot be removed with surgery.
Select...
I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate
Secondary outcome measures
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%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
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%
TUMOR PAIN
9%
ORAL 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%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
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: 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
~1080

Find a Location

Who is running the clinical trial?

ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,501 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Cabozantinib drug's regulatory status?

"Because there is only limited data supporting Cabozantinib's safety, it received a score of 2."

Answered by AI

What medical conditions does Cabozantinib usually address?

"Patients that have received anti-VEGF treatment, those with advanced renal cell carcinoma (aRCC), and those with adrenal medulla can all be treated using Cabozantinib."

Answered by AI

How many people fit the eligibility requirements for this clinical trial?

"That is correct. The clinical trial, which was originally posted on 6/10/2021 and most recently edited on 11/16/2022, is presently recruiting participants, as stated on clinicaltrials.gov. This particular trial is looking for 50 patients at 1 location."

Answered by AI

What is the efficacy of Cabozantinib in comparison to other treatments?

"As of right now, there are 116 ongoing clinical trials that involve Cabozantinib with 13 being in Phase 3. A large number of these research studies are based in Cordoba and Calabria, but there are also 7150 other locations around the world conducting similar investigations."

Answered by AI

Are researchers looking for new participants in this trial right now?

"That is accurate. The information available on clinicaltrials.gov indicates that this study, which was first announced on June 10th 2021, is still actively seeking patients for enrollment. A total of 50 individuals are needed at a single site."

Answered by AI

Has this type of research been done before?

"Since 2012, there have been 116 ongoing clinical trials for cabozantinib in 1375 cities and 46 countries. The initial study was conducted in 2012 by Exelixis and involved 86 patients. After the first trial, cabozantinib received Phase 2 drug approval."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II Trial of Cabozantinib With Patients With Refractory GCTs
Jennifer King 2021. "A Phase II Trial of Cabozantinib With Patients With Refractory GCTs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876456.
~9 spots leftby Dec 2024
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