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Tyrosine Kinase Inhibitor

Oral Tablet: Cabozantinib for Colorectal Cancer

Phase 2
Waitlist Available
Led By Wells Messersmith, MD
Research Sponsored by Academic Thoracic Oncology Medical Investigators Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, or death, whichever comes first, up to 24 months
Awards & highlights

Study Summary

This trial will test whether Cabozantinib can help treat people with metastatic colorectal cancer who haven't responded to other treatments.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, or death, whichever comes first, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, or death, whichever comes first, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-Week Progression Free Survival
Secondary outcome measures
12-Week Progression-Free Survival by PIK3CA Mutation Status
12-Week Progression-Free Survival by RAS Mutation Status
Overall Survival (OS) by PIK3CA Mutation Status
+6 more

Side effects data

From 2022 Phase 2 trial • 44 Patients • NCT03542877
64%
Fatigue
52%
Diarrhea
39%
Nausea
39%
Pain
36%
Anorexia
36%
Abdominal Pain
34%
Hypertension
32%
Constipation
32%
palmar-plantar erythrodysesthesia
32%
Weight loss
27%
Proteinuria
27%
vomiting
23%
Cramping
23%
Hypothyroidism
20%
Edema
20%
Reflux
20%
Aspartate aminotransferase increased
18%
Hypokalemia
18%
thrombocytopenia
18%
fever
16%
Cough
16%
Alkaline phosphatase increased
16%
alanine aminotransferase increase
16%
Anemia
16%
Dizziness
16%
Dysgeusia
16%
Hematuria
14%
Ache
14%
Leukopenia
14%
Pruritus
14%
sore throat
14%
Bilirubin Increased
14%
Rash
11%
Dyspnea
11%
Flatulence
11%
Hyperamylasemia
11%
Mucositis
9%
Elevated Creatinine
9%
Xerostomia
9%
hoarse
9%
Chills
9%
Hyperlipasemia
9%
Hypoalbuminemia
9%
TSH elevated
7%
Pleural Effusion
7%
Lymphocytopenia
7%
Blurred vision
7%
chest pain
7%
forgetfulness
7%
Hypertention
7%
Acid Reflux
7%
Acne
7%
Alopecia
7%
Amylase increased
7%
Skin sensitivity
7%
Congestion
7%
Hyperglycemia
7%
Dry Skin
5%
Urinary Retention
5%
Mouth Sores
5%
GI bleed
5%
Lung infection
5%
Alanine aminotransferase increased
5%
Distended Abdomen
5%
Weakness
5%
Dental Caries
5%
Mood alteration
5%
Migraine
5%
Change in Hair Color
5%
Neutropenia
5%
Myalgia
5%
Hypotension
5%
Dysesthesia
5%
Elevated Urine Protein Creatinine Ratio
5%
Disease Progression
5%
dyspnea
5%
Bloating
5%
Gait Disturbance
5%
hypopigmentation
5%
Hyponatremia
5%
Neuropathy
5%
Decreased Appetite
5%
Sepsis
2%
Hyperuricemia
2%
Hyperkalemia
2%
bradycardia
2%
Elevated troponin
2%
Hearing Loss
2%
Ascites
2%
Deep Vein Thrombosis
2%
Hypoxia
2%
nausea
2%
Pneumonia
2%
Progressed Malignant Neoplasm
2%
Pulmonary Embolism
2%
Severe Complicated Bilateral Pyelonephritis
2%
Abdominal Tenderness
2%
Hypersomnia
2%
Hypocalcemia
2%
Hypernatremia
2%
Tonsilitis
2%
Spinal Fracture
2%
Thrombocytopenia
2%
Dehydration
2%
Acute Pancreatitis
2%
Acute Renal Failure
2%
Weight Gain
2%
Increased Creatinine
2%
Disseminated Intravascular Coagulation
2%
Duodenal fistula
2%
fecal impaction
2%
Numbness of skin
2%
Burning mouth syndrom
2%
Cavitating Pulmonary Nodules
2%
Acute Cerebrovascular Accident
2%
Back Pain
2%
Bowel Perforation
2%
difficulty speaking
2%
Failure to Thrive
2%
Bowel Obstruction
2%
Vomiting
2%
Mouth Sensitivity
2%
Elevated Liver Function Test
2%
Tachycardia
2%
Lactate Increased
2%
Ulcer
2%
Malnutrition
2%
Infection
2%
epistaxis
2%
Syncope
2%
Conduction Disorder
2%
Wound bleeding
2%
Jaw pain
2%
Urine Discoloration
2%
Jaundice
2%
Pancreatitis
2%
Bruising
2%
Neurological Changes
2%
Shock
2%
Tumor Lysis Syndrome
2%
Diaphoresis
2%
Laryngitis
2%
sinusitis
2%
Bleeding gums
2%
Abdominal Distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Cabozantinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral CabozantinibExperimental Treatment1 Intervention
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Tablet: Cabozantinib
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Academic Thoracic Oncology Medical Investigators ConsortiumLead Sponsor
4 Previous Clinical Trials
145 Total Patients Enrolled
University of Colorado, DenverOTHER
1,738 Previous Clinical Trials
2,149,482 Total Patients Enrolled
Wells Messersmith, MDPrincipal InvestigatorUniversity of Colorado, Denver
8 Previous Clinical Trials
388 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer
2018. "Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03542877.
~6 spots leftby Apr 2025
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