Cabozantinib S-malate for Prostate Cancer

Huntsman Cancer Institute/University of Utah, Salt Lake City, UT
Prostate Cancer+4 More ConditionsCabozantinib S-malate - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether cabozantinib and atezolizumab can shrink tumors in patients with metastatic castrate-resistant prostate cancer.

Eligible Conditions
  • Stage IV Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Stage IVB Prostate Cancer
  • Stage IVA Prostate Cancer
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Cabozantinib S-malate
1
Cabozantinib S-malate
1
Cyclophosphamide

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From trial initiation and death of any cause, assessed up to 5 years

At 24 weeks
Disease control rate
Day 30
PSA levels
Year 3
Progression-free survival (PFS)
Year 3
Prostate-specific antigen (PSA) progression-free survival (PFS)
Year 5
Overall survival
Day 30
Incidence of adverse events (AEs)

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Cabozantinib S-malate
1
Cabozantinib S-malate
1
Cyclophosphamide

Side Effects for

Cabozantinib
85%Fatigue
77%Nausea
62%Dysgeusia
62%Vomiting
54%Aspartate Aminotransferase Increased
54%Mucositis Oral
54%Abdominal Pain
54%Alkaline Phosphatase Increased
46%Anorexia
46%Hypertension
38%Alanine Aminotransferase Increased
38%Weight Loss
38%Anemia
38%Diarrhea
38%Constipation
38%Cough
38%Thromboembolic Event
38%Dyspnea
31%Hypomagnesemia
31%Back Pain
31%Lipase Increased
31%Hypoalbuminemia
23%Hyperglycemia
23%Palmar-Plantar Erythrodysesthesia Syndrome
23%Hypophosphatemia
23%Alopecia
23%Hypothyroidism
23%Oral Pain
23%Pain
23%Dizziness
23%Pain In Extremity
23%Headache
15%Insomnia
15%Myalgia
15%Sore Throat
15%White Blood Cell Decreased
15%Activated Partial Thromboplastin Time Prolonged
15%Abdominal Distension
15%Platelet Count Decreased
15%Dry Mouth
15%Dyspepsia
15%Bloating
15%Dehydration
15%Hypocalcemia
15%Dry Skin
15%Flushing
15%Peripheral Sensory Neuropathy
8%Neutrophil Count Decreased
8%Hyponatremia
8%Pleural Effusion
8%Pleuritic Pain
8%Nail Discoloration
8%Proteinuria
8%Nasal Congestion
8%Bone Pain
8%Hoarseness
8%Creatinine Increased
8%Flank Pain
8%Ventricular Tachycardia
8%Pancreatitis
8%Upper Respiratory Infection
8%Bruising
8%Weight Gain
8%Arthralgia
8%Syncope
8%Tinnitus
8%Gastrointestinal Pain
8%Floaters
8%Gastroesophageal Reflux Disease
8%Chest Pain - Cardiac
8%Vertigo
8%Dysphagia
8%Blood Bilirubin Increased
8%Lung Infection
8%Fever
8%Depression
8%Hypersomnia
8%Generalized Muscle Weakness
8%Skin Induration
8%Hypotension
8%Productive Cough
8%Memory Impairment
8%Anxiety
8%Cardiac Troponin I Increased
8%Urinary Incontinence
8%Allergic Rhinitis
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02315430) in the Cabozantinib ARM group. Side effects include: Fatigue with 85%, Nausea with 77%, Dysgeusia with 62%, Vomiting with 62%, Aspartate Aminotransferase Increased with 54%.

Awards & Highlights

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.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (cabozantinib, atezolizumab)
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib S-malate · No Placebo Group · Phase 2

Treatment (cabozantinib, atezolizumab)Experimental Group · 2 Interventions: Cabozantinib S-malate, Atezolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from trial initiation and death of any cause, assessed up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,695 Total Patients Enrolled
543 Trials studying Prostate Cancer
503,595 Patients Enrolled for Prostate Cancer
University of UtahLead Sponsor
1,022 Previous Clinical Trials
1,776,342 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Umang SwamiPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Eligibility Criteria

Age 18+ · Male Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What medical conditions is Cabozantinib S-malate typically employed to combat?

"Small cell lung cancer is typically treated with Cabozantinib S-malate, though it can also be utilized to help patients who have previously been exposed to anti-vegf treatments, or those that are diagnosed with a malignant neoplasm and deemed at high risk." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this experiment still available to participants?

"Indeed, clinicaltrials.gov reports that this trial is actively recruiting participants. It was initially made available on March 11th 2022 and recently updated for the same date. The research team needs 33 individuals from a single location to take part in the study." - Anonymous Online Contributor

Unverified Answer

What sort of health hazards could be associated with Cabozantinib S-malate?

"Based on our evaluation at Power, Cabozantinib S-malate is given a score of 2 for safety. This is because it has been tested in Phase 2 trials and there is documentation supporting its safety but not yet any proof that the drug can effectively treat the condition." - Anonymous Online Contributor

Unverified Answer

Is this an inaugural clinical trial of its kind?

"As of now, 446 studies are active for Cabozantinib S-malate across 1911 cities and 75 countries. The initial trial involving this drug occurred in 2008 and was sponsored by Hoffmann-La Roche, recruiting 720 patients to complete its Phase 2 approval process. Subsequently, 135 trials have been finalized since then." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment threshold for this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov implies that the trial is currently enrolling patients, which were first mentioned on March 11th 2022 and updated most recently in the same month. 33 participants are required for this study at 1 medical facility." - 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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