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Immunosuppressant
Selumetinib + Cyclosporine for Colorectal Cancer
Phase 1
Waitlist Available
Led By Christopher H Lieu
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DOSE ESCALATION PHASE: Histological or cytopathological diagnosis of an advanced cancer that is refractory to standard therapy or for which no standard therapy exists
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5, 1, 2, 4, 8, and 24 hours on days -7, -3, and 1 of course 1
Awards & highlights
Study Summary
This trial is testing the effects of selumetinib in combination with cyclosporine on patients with solid tumors or colorectal cancer.
Who is the study for?
This trial is for adults with advanced solid tumors or colorectal cancer that's spread and can't be treated or controlled. They must have had certain treatments, not have specific mutations, and be healthy enough overall (good organ function, no severe heart conditions). Participants need to consent, use contraception if needed, and have a life expectancy over 3 months.Check my eligibility
What is being tested?
The trial tests selumetinib combined with cyclosporine to see the effects on tumor growth by blocking enzymes needed for cell growth and modifying immune responses. It aims to find the best dose with acceptable side effects in patients whose cancers haven't responded to standard therapies.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from compounds like AZD6244 or cyclosporine A. There may also be risks of high blood pressure, heart issues like arrhythmias or low ejection fraction, eye problems such as increased pressure or retinopathy, liver function changes, and electrolyte imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer does not respond to standard treatments or no standard treatment exists.
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I am fully active or can carry out light work.
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I am using birth control and had a negative pregnancy test recently.
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My kidney function, measured by eGFR, is normal or above 60.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose, 0.5, 1, 2, 4, 8, and 24 hours on days -7, -3, and 1 of course 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 4, 8, and 24 hours on days -7, -3, and 1 of course 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLT defined as any grade 3 non-hematological toxicity or grade 4 hematological toxicity attributed to selumetinib or cyclosporine graded per National Cancer Institute (NCI) CTCAE version 4.0
Secondary outcome measures
Incidence of adverse events that occur after course 1, day 1 assessed using NCI CTCAE version 4.0
Objective tumor response based on computed tomography scans (or magnetic resonance imaging if patients are allergic to iodinated contrast) per RECIST 1.1 criteria
Pharmacokinetic (PK) parameters, including the distribution of area under the curve and maximum concentration
+1 moreOther outcome measures
Mitogen-Activated Protein Kinases
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selumetinib and cyclosporine)Experimental Treatment4 Interventions
Patients receive selumetinib PO BID on day -7 of course 1 and then on days 1-28 (one dose on day 1 only). Patients also receive cyclosporine PO BID on day -3 of course 1 and then on days 1-28 (one dose on day 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Cyclosporine
1997
Completed Phase 3
~1830
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
Christopher H LieuPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured using specific criteria.My advanced cancer does not respond to standard treatments or no standard treatment exists.I am fully active or can carry out light work.I have a tumor that can be safely biopsied.My colorectal cancer is advanced, cannot be surgically removed, and I know my RAS status. I cannot join if I have BRAF mutations and have already tried treatments with oxaliplatin and irinotecan.My blood calcium level is below 8.4 mg/dL, but I can take supplements to increase it.I haven't had a stroke, mini-stroke, or blood clot in my lungs in the last 6 months.My blood pressure is controlled and below 140/90 mmHg.I do not have any severe illnesses or conditions that my doctor is still trying to get under control.I have eye conditions like high pressure, uncontrolled glaucoma, or past eye vein issues.I cannot swallow pills.I am not pregnant and will stop breastfeeding if treated with AZD6244.My blood potassium level is below 3.5 mmol/L.My blood clotting time is within the normal range, or I'm on warfarin for blood clots.I am using birth control and had a negative pregnancy test recently.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I have advanced colorectal cancer that cannot be surgically removed, know my RAS status, and cannot take BRAF mutation treatments. I've also had and didn't respond well to treatments with oxaliplatin and irinotecan.My kidney function, measured by eGFR, is normal or above 60.I am allergic to AZD6244, cyclosporine A, or similar drugs.I have moderate heart valve disease.I take medication other than beta blockers or digoxin for heart rhythm problems.I am a man who can father children and will use birth control during and up to 12 weeks after the study.I have a tumor that can be safely biopsied.You are expected to live for at least three more months.I have brain metastases but am stable and not on recent steroids or anti-convulsants for it.I haven't had extensive radiotherapy in the last 4 weeks or targeted radiotherapy in the last 2 weeks.My advanced cancer does not respond to standard treatments or no treatment exists.I have moderate to severe heart failure.I haven't had major surgery or significant injury in the last 3 weeks, or minor procedures like a biopsy in the last week.I haven't had a recent heart attack or unstable heart disease in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selumetinib and cyclosporine)
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.
Are there any other examinations that have been conducted with Selumetinib?
"At this moment, 100 investigations into the efficacy of Selumetinib are in progress, with 17 trials reaching Phase 3. Although a majority of these studies are located near Houston, Texas; 1,465 sites across the world are conducting research related to Selumetinib."
Answered by AI
What is the total participant count of this clinical experiment?
"This trial has concluded its recruitment process. It was first listed on August 5th 2014 and the listing was last updated November 16th 2022. If you're searching for other studies, there are 874 clinical trials involving colorectal carcinoma that are currently admitting patients and 100 trials using Selumetinib recruiting participants."
Answered by AI
What therapeutic purposes does Selumetinib serve?
"Selumetinib is regularly employed in transplantation treatments. It can also assist with issues like watery eyes, lupus nephritis, and bulla."
Answered by AI
How many medical centers are hosting this investigation?
"This trial encompasses 10 medical sites, among those Chapel Hill, New Brunswick and Pittsburgh. To minimize the need for travel, it is suggested to select a local clinic if possible."
Answered by AI
Has the Food and Drug Administration sanctioned Selumetinib for medical use?
"Our assessment of Selumetinib's safety level on a scale of 1 to 3 was determined to be 1 due to the limited evidence available in this phase one trial."
Answered by AI
Are researchers actively seeking participants for this experiment?
"As per the records on clinicaltrials.gov, this research endeavour is not currently recruiting participants. The trial was initially posted in August 2014 and last updated November 16th 2022, but there are presently 974 other studies looking for volunteers."
Answered by AI
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