Cabozantinib for Germ Cell Tumors

Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, IN
Germ Cell Tumors+3 More ConditionsCabozantinib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Germ Cell Tumors
  • Ovarian Germ Cell Tumor
  • Non-Seminomatous Germ Cell Tumors
  • Seminoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Start of the treatment until time of death or last follow up visit (up to 2 years)

Year 2
Overall survival
Progression free survival
Year 1
Incidence of Adverse Events
up to 1 year
Clinical benefit rate
Objective response rate

Trial Safety

Phase-Based Safety

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

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Side Effects for

Cohort A
78%WEIGHT LOSS
74%GAIT DISTURBANCE
65%Joint Pain
65%White Blood Cell Count Decreased
57%ABSOLUTE NEUTROPHIL COUNT INCREASED
43%BUN INCREASED
43%Skin Blisters
43%Blood Bilirubin Increased
43%HEADACHE
39%HOT FLASHES
39%Chest Pain
39%BLURRED VISION
35%Panic Attack
35%Total Protein Level Increased
26%SKIN INFECTION
26%HEMATURIA
26%FLUSHING
26%Toothache
26%DYSGEUSIA
22%ABDOMINAL PAIN
22%Neutrophil Count Decreased
22%Emotional Lability
17%ABSOLUTE NEUTROPHIL COUNT DECREASED
17%Dyspnea
17%Muscle Weakness Lower Limb
17%WEIGHT GAIN
17%HYPOTHYROIDISM
17%Cold Sore
17%CONSTIPATION
17%HYPOALBUMINEMIA
17%Urobilinogen Increased
13%PAIN IN EXTREMITY
13%WHITE BLOOD CELL INCREASED
13%DEHYDRATION
13%TUMOR PAIN
13%URINARY URGENCY
13%Decreased Platelet Count
13%Myalgia
13%Vitamin D Deficiency
13%HYPOMAGNESEMIA
13%PROTEINURIA
13%HYPOPIGMENTATION
13%Hypermagnesemia
13%Tinnitus
13%PARONYCHIA
13%ALANINE AMINOTRANSFERASE DECREASED
13%BILIRUBIN INCREASED
13%DIARRHEA
13%HYPERGLYCEMIA
9%DRY MOUTH
9%ANOREXIA
9%HYPONATREMIA
9%Dislocation
9%Flatulence
9%Gastrointestinal Disorders - Other, Dental Pain
9%Tooth Infection
9%SINUS BRADYCARDIA
9%VERTIGO
9%ORAL PAIN
9%HYPERTENSION
9%DYSPEPSIA
9%VOMITING
9%LYMPHOCYTE COUNT DECREASED
9%HYPOCALCEMIA
9%ERYTHEMA
9%MACULOPAPULAR RASH
9%Facial Pain
9%Neck Pain
9%Sinus Tachycardia
9%Suicidal Ideation
9%White Blood Cell Count Increased
9%HYPOGLYCEMIA
9%Skin And Subcutaneous Tissue Disorders- Other, Erythema
9%Urine White Blood Cell Increased
4%ABSCESS
4%ORAL DYSESTHESIA
4%PANCREATITIS
4%FATIGUE
4%EDEMA LIMBS
4%ALANINE AMINOTRANSFERASE INCREASED
4%PLATELET COUNT DECREASE
4%HYPOPHOSPHATEMIA
4%ANXIETY
4%INSOMNIA
4%URINARY FREQUENCY
4%URINARY TRACT INFECTION
4%IRREGULAR MENSTRUATION
4%NASAL CONGESTION
4%ACNEIFORM RASH
4%DRY SKIN
4%HAIR COLOR CHANGE
4%TINEA PEDIS
4%Dental Caries
4%Depression
4%Epistaxis
4%Hemorrhoids
4%Hyperkalemia
4%Investigations - Other, Eosinophilia
4%Pale Skin
4%Rash Acneiform
4%Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
4%Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
4%Tooth Extraction
4%Tremor
4%HYPERTHYROIDISM
4%BLOATING
4%NAUSEA
4%SERUM AMYLASE INCREASED
4%THYROID STIMULATING HORMONE INCREASED
4%URINARY RETENTION
4%BULLOUS DERMATITIS
4%Alopecia
4%Fever
4%Productive Cough
4%Rash Maculopapular
4%Tachycardia
4%Wound Infection
4%PAIN
4%ABSOLUTE LYMPHOCYTE COUNT INCREASED
4%ALKALINE PHOSPHATASE INCREASED
4%ASPARTATE AMINOTRANSFERASE INCREASED
4%HEMOGLOBIN INCREASED
4%CALLUS OF FOOT
4%PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
4%RASH
4%Arthralgia
4%Concentration Impairment
4%Muscle Pain
4%Muscle Weakness
4%Paresthesia
4%Peripheral Motor Neuropathy
4%Platelet Count Decreased
4%Upper Respiratory Infection
4%PALPITATIONS
4%LIPASE INCREASED
4%HYPOKALEMIA
4%DIZZINESS
4%Back Pain
4%Cough
4%Laryngeal Inflammation
4%Metabolism Other - Decreased Vitamin D
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT02101736) in the Cohort A ARM group. Side effects include: WEIGHT LOSS with 78%, GAIT DISTURBANCE with 74%, Joint Pain with 65%, White Blood Cell Count Decreased with 65%, ABSOLUTE NEUTROPHIL COUNT INCREASED with 57%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Cabozantinib
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · Phase 2

Cabozantinib
Drug
Experimental Group · 1 Intervention: Cabozantinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: start of the treatment until time of death or last follow up visit (up to 2 years)

Who is running the clinical trial?

Jennifer KingLead Sponsor
Nabil AdraLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
2 Trials studying Germ Cell Tumors
82 Patients Enrolled for Germ Cell Tumors
ExelixisIndustry Sponsor
110 Previous Clinical Trials
17,898 Total Patients Enrolled
Junnifer King, MDPrincipal InvestigatorIndiana University
Nabil Adra, MD5.01 ReviewsPrincipal Investigator - Indiana University
Indiana University
4 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Germ Cell Tumors
64 Patients Enrolled for Germ Cell Tumors
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!

Eligibility Criteria

Age Any Age · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What is the Cabozantinib drug's regulatory status?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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