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Kinase Inhibitor
Hydroxychloroquine + Encorafenib/Cetuximab for Colorectal Cancer
Phase 2
Recruiting
Led By Devalingam Mahalingam, MD, PhD
Research Sponsored by Northwestern University
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 within 30 days (+/- 7 days) of coming off treatment
Awards & highlights
Study Summary
This trial studies adding hydroxychloroquine to cancer treatments to improve effectiveness in BRAF V600E colon cancer patients.
Who is the study for?
Adults with stage IV colorectal cancer that has the BRAF V600E mutation, who have tried at least one other treatment but not BRAF inhibitors. They must be in good health otherwise, with no severe heart or eye conditions, and can't be pregnant or nursing. Participants need to have recovered from previous treatments and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing hydroxychloroquine combined with encorafenib and cetuximab (or panitumumab) on patients whose colorectal cancer has resisted prior treatments. The goal is to see if adding hydroxychloroquine helps overcome resistance to standard therapy.See study design
What are the potential side effects?
Possible side effects include vision problems due to hydroxychloroquine, skin reactions from cetuximab or panitumumab, liver issues from encorafenib, as well as general fatigue, nausea, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days (+/- 7 days) of coming off treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days (+/- 7 days) of coming off treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Adverse Events
Duration of Response (DoR)
Duration of Stable Disease (DoSD)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Hydroxychloroquine)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
916,976 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,811 Total Patients Enrolled
Devalingam Mahalingam, MD, PhDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain or spinal cord.I have a history of pancreatitis.I have another cancer that won't affect this treatment's safety or results.I am not pregnant or nursing.I haven't had chemotherapy or radiotherapy in the last 14 days.My organs and bone marrow are functioning well.I stopped my previous cancer treatments at least 14 days ago.I haven't taken strong CYP3A4/5 inhibitors or inducers in the last week.I can swallow pills and don't have major stomach or intestine issues.I am not pregnant and agree to use birth control.I am 18 years old or older.I have HIV but my viral load is undetectable with treatment.My brain cancer has not worsened after treatment.I have recovered from previous cancer treatments with minimal side effects.My heart condition does not severely limit my physical activity.I do not have any uncontrolled illnesses like heart problems or infections.I have conditions like psoriasis or porphyria.I am fully active or can carry out light work.My colorectal cancer is stage IV with a BRAF V600E mutation, and I've had at least one treatment but no BRAF inhibitors.I have chronic hepatitis B but it's under control with medication.I had hepatitis C but am now cured or currently being treated with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Hydroxychloroquine)
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.
Is it still possible to join this medical experiment?
"Clinicaltrials.gov states that this experiment is actively recruiting patients, with the initial post being made on October 10th 2022 and an alteration occurring on November 16th 2022."
Answered by AI
How many participants is the research team accepting for this trial?
"Affirmative. According to clinicaltrials.gov, this medical experiment is presently recruiting participants and was first posted on October 10th 2022. The most recent edits were done on November 16th 2022 and the research team requires 43 volunteers at one location."
Answered by AI
To what degree can Hydroxychloroquine be relied upon as a safe treatment option?
"Given the lack of clinical data confirming efficacy and some evidence for safety, Treatment (Hydroxychloroquine) was rated a 2 on our scale from 1 to 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
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