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Antiviral
Lamivudine for Colorectal Cancer
Phase 2
Waitlist Available
Led By Aparna R. Parikh, MD
Research Sponsored by Massachusetts General Hospital
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 2 years
Awards & highlights
Study Summary
This trial is looking at whether or not lamivudine can help treat people with metastatic colorectal cancer who have a mutation in the p53 gene.
Eligible Conditions
- Metastatic Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Overall Disease Control Rate
Overall Survival
Progression Free Survival
Side effects data
From 2015 Phase 3 trial • 3526 Patients • NCT000745818%
Blood bilirubin increased
8%
Blood phosphorus decreased
8%
Abnormal loss of weight
7%
Neutropenia
7%
Neutrophil count decreased
5%
Hypophosphataemia
4%
Aspartate aminotransferase increased
4%
Hyperbilirubinaemia
3%
Malaria
2%
Alanine aminotransferase increased
2%
Anaemia
2%
Pneumonia
2%
Haemoglobin decreased
2%
Dizziness
1%
Hypertension
1%
Blood albumin decreased
1%
Diarrhoea
1%
Blood sodium decreased
1%
Dyslipidaemia
1%
Abortion spontaneous
1%
Completed suicide
1%
Suicidal ideation
1%
Thrombocytopenia
1%
Deep vein thrombosis
1%
Diarrhoea haemorrhagic
1%
Gastroenteritis
1%
Pelvic inflammatory disease
1%
Pneumonia bacterial
1%
Platelet count decreased
1%
Transaminases increased
1%
Abortion incomplete
1%
Death
1%
Hepatotoxicity
1%
Urinary tract infection
1%
Suicide attempt
100%
80%
60%
40%
20%
0%
Study treatment Arm
Early-ART
Delayed-ART
Trial Design
1Treatment groups
Experimental Treatment
Group I: LamivudineExperimental Treatment1 Intervention
Lamivudine administered orally every 4 weeks
Treatment cycles will last 28 consecutive days
The dosage will be determine by the PI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamivudine
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,913 Total Patients Enrolled
Aparna R. Parikh, MDPrincipal InvestigatorMassachusetts General Hospital
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