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Anti-metabolites
CB-839 + Capecitabine for Colorectal Cancer
Phase 1 & 2
Waitlist Available
Led By David Bajor, MD
Research Sponsored by David Bajor
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 up to 18 months after beginning treatment
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is effective and safe.
Eligible Conditions
- Colorectal Cancer
- Colon Cancer
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months after beginning treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months after beginning treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PHASE 1: Recommended dose for phase II study
PHASE 2: Number of patients with response to treatment
Secondary outcome measures
PHASE 1: proportion of patient who respond to treatment
Side effects data
From 2020 Phase 2 & 3 trial • 151 Patients • NCT0309387063%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Pyrexia
42%
Hypokalaemia
38%
Abdominal Pain
33%
Constipation
33%
Blood Bilirubin Increased
29%
Abdominal Distension
29%
Hyponatraemia
29%
Dizziness
29%
Oedema Peripheral
29%
Back Pain
25%
Hypotension
25%
Stomatitis
25%
Palmar-plantar Erythrodysaethesia Syndrome
25%
Dehydration
25%
Anaemia
21%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Depression
8%
Gastrooesophageal Reflux Disease
8%
Gamma-glutamyltransferase increased
8%
International normalised ratio increased
8%
Paraesthesia
8%
Influenza like illness
8%
Dysphonia
8%
Malaise
8%
Hypoaesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hyponatremia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo and Capecitabine - Part 1
Varlitinib and Capecitabine - Safety Lead-In
Varlitinib and Capecitabine - Part 1
Trial Design
1Treatment groups
Experimental Treatment
Group I: CB-839 + capecitabineExperimental Treatment2 Interventions
Patients will receive CB-839 orally twice daily for 21 days (continuous administration) and capecitabine orally twice daily for 14/21 days. In the phase I portion of the study, patients will receive escalating doses of CB-839 and capecitabine and will have day 15 blood samples drawn and archived for as needed assessment of CB-839 pharmacokinetics. In the phase II portion of the study, patients will receiving 800mg CB-839 and 1000mg/m^2 capecitabine as were determined to be safe doses during the phase I portion of the study. They will also undergo pre-treatment and post-treatment blood samples and tissue biopsies for evaluation of pharmacodynamic biomarkers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CB-839
2017
Completed Phase 2
~850
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
David BajorLead Sponsor
1 Previous Clinical Trials
49 Total Patients Enrolled
David Bajor, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
3 Previous Clinical Trials
115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: CB-839 + capecitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can the clinical trial accomodate?
"Unfortunately, this clinical research is not recruiting participants right now. It was initially announced on September 12th 2016 and was recently updated on the 14th of September 2022. For those still wanting to participate in a related study, there are 1751 trials enrolling patients with rectal carcinoma and 340 studies seeking volunteers for Capecitabine treatment."
Answered by AI
Are there any supplementary investigations which have employed Capecitabine?
"At present, 340 trials are researching the efficacy of Capecitabine with 126 in Phase 3. Most studies for this drug can be found in Woolloongabba, Queensland but there are many more locations offering clinical trials involving Capecitabine (12902 worldwide)."
Answered by AI
Are there still opportunities to join this medical trial?
"This study has already completed its recruitment phase, having first been uploaded on September 12th 2016 and last edited on the 14th of September. However, there are currently 1751 clinical trials recruiting patients with rectal carcinoma and 340 trials actively enrolling participants for Capecitabine treatments."
Answered by AI
What ailments is Capecitabine commonly employed to remediate?
"Malignant neoplasms are commonly treated with Capecitabine, and this medication also has applications in treating refractory ovarian cancer, pancreatic endocrine carcinoma, as well as colorectal carcinoma."
Answered by AI
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