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Antiviral

A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic 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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing Lamivudine to see if it can treat patients with a specific type of colon cancer that has a p53 mutation. The drug may help by stopping the cancer cells from growing and spreading.

Eligible Conditions
  • Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Overall Disease Control Rate
Overall Survival
Progression Free Survival

Side effects data

From 2015 Phase 3 trial • 3526 Patients • NCT00074581
8%
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%
Blood albumin decreased
1%
Hypertension
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

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-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,023 Previous Clinical Trials
13,317,913 Total Patients Enrolled
Aparna R. Parikh, MDPrincipal InvestigatorMassachusetts General Hospital
~4 spots leftby Dec 2025
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