Cabozantinib for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal Cancer+9 More
Cabozantinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a drug combo can help patients with a certain type of cancer that has spread and is hard to treat.

Eligible Conditions
  • Colorectal Cancer
  • Rectal Adenocarcinoma
  • Colorectal Carcinoma
  • Rectum Cancer
  • Adenocarcinoma
  • Malignant Neoplasm of Colon
  • Rectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Study start date to study end date, up to 24 months

Month 24
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Safety and Tolerability
Month 24
Exploratory Biomarker analysis - Tumor tissue
Exploratory Biomarker analysis - Whole Blood

Trial Safety

Safety Progress

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

Side Effects for

Cohort 3 - Cabozantinib for ER-, PR-, HER2-
88%Fatigue
63%Vomiting
50%Pain
38%Musculoskeletal and connective tissue disorder - Other, specify
38%Aspartate aminotransferase increased
38%Diarrhea
38%Alanine aminotransferase increased
25%Dehydration
25%Cough
25%Insomnia
25%Skin and subcutaneous tissue disorders - Other, specify
25%Pain in extremity
25%Nausea
25%Gastrointestinal disorders - Other, specify
25%Back pain
25%Anorexia
25%Dysgeusia
25%Anxiety
25%Dry skin
25%Constipation
25%Mucositis oral
13%General disorders and administration site conditions - Other, specify
13%Platelet count decreased
13%Neck pain
13%Headache
13%Ataxia
13%Hypertension
13%Lipase increased
13%Palmar-plantar erythrodysesthesia syndrome
13%Dry mouth
13%Tracheal fistula
13%Personality change
13%Alkaline phosphatase increased
13%Bruising
13%Epistaxis
13%Hypomagnesemia
13%Rash maculo-papular
13%Blood bilirubin increased
13%Depression
13%Irregular menstruation
13%Nail discoloration
13%Upper respiratory infection
13%Seizure
13%Thromboembolic event
13%Hyponatremia
13%Bloating
13%Blood and lymphatic system disorders - Other, specify
13%Gastroesophageal reflux disease
13%Endocrine disorders - Other, specify
13%Dysphasia
13%Hypothyroidism
13%Dyspepsia
13%Abdominal pain
13%Peripheral sensory neuropathy
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 3 - Cabozantinib for ER-, PR-, HER2- ARM group. Side effects include: Fatigue with 88%, Vomiting with 63%, Pain with 50%, Musculoskeletal and connective tissue disorder - Other, specify with 38%, Aspartate aminotransferase increased with 38%.

Trial Design

1 Treatment Group

Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28...
1 of 1

Experimental Treatment

46 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · Phase 2

Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days.Experimental Group · 2 Interventions: Nivolumab, Cabozantinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study start date to study end date, up to 24 months

Who is running the clinical trial?

ExelixisIndustry Sponsor
108 Previous Clinical Trials
17,142 Total Patients Enrolled
Criterium, Inc.Industry Sponsor
15 Previous Clinical Trials
888 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,570 Previous Clinical Trials
1,923,754 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,483 Previous Clinical Trials
3,919,830 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,881 Total Patients Enrolled
Alexis Leal, MDPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
a biopsy confirms the diagnosis The person has cancer that started in the colon or rectum and has spread to other parts of the body, or it can't be removed with surgery.
The patient did not tolerate, is refractory to or progresses (or relapses) after treatment with a fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab.
Patients with left-sided, RAS wild-type tumors should have prior epidermal growth factor inhibitor therapy.
The patient has a measurable disease as determined by the investigator using RECIST v.1.1.
the subject has a measurable lesion and there is evidence of disease progression on or after the Baseline scan
defined as MSH2 and MSH6 tumor expression levels ≥ 1.5-fold) Patients must have proficient mismatch repair (pMMR; defined as MSH2 and MSH6 tumor expression levels ≥ 1.5-fold)
however, TAS-102 must not be administered to patients with a history of severe hypersensitivity reactions to it
Patients must have a known RAS and BRAF status as per local standard of practice.
The subject has had a CT scan and/or MRI to assess all known disease sites within 28 days before the first dose of cabozantinib.
You must be at least 18 years old to give consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
UCHealth Memorial Hospital Central100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. UCHealth Memorial Hospital Central: < 48 hours