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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 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

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 • 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%
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
2,932 Previous Clinical Trials
13,198,459 Total Patients Enrolled
Aparna R. Parikh, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Lamivudine been granted sanction by the U.S. Food and Drug Administration?

"While Lamivudine has not been proven to be effective in a clinical setting, there is evidence assigning it an estimated safety rating of 2."

Answered by AI

How many participants are being included in this experiment?

"This investigation is not presently recruiting. It was initially posted on October 31st, 2017 and the latest data update happened on August 25th 2021. For those seeking other trials, 876 clinical studies are currently enrolling patients with colorectal cancer and 39 for Lamivudine alone have vacancies available to join."

Answered by AI

What additional investigations have investigated Lamivudine's potential?

"Currently, 39 Lamivudine-based clinical trials are in progress; 15 of which are Phase 3. Most research for this drug is being conducted in Orlando, FL but there other sites scattered across the country that also host these studies."

Answered by AI

Are there still open enrollment opportunities for this experiment?

"Currently, this trial is not recruiting participants. It was first advertised in October of 2017 and last edited on August 25th 2021. If you are searching for a different medical study, there are 876 studies looking for individuals with colorectal cancer along with 39 trials using Lamivudine actively seeking patients."

Answered by AI

To what diseases is Lamivudine commonly applied as a treatment?

"Lamivudine has been successfully employed to combat perinatal HIV transmission, antiretroviral treatment, and chronic Hepatitis b."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
Aparna Parikh 2017. "A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03144804.
~5 spots leftby Apr 2025
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