40 Participants Needed

Selumetinib + Cyclosporine for Colorectal Cancer

Recruiting at 10 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the combination of Selumetinib and Cyclosporine in patients with advanced cancers that do not respond to standard treatments. Selumetinib blocks growth signals in cancer cells, while Cyclosporine helps by modifying the immune system. Cyclosporine is an immunosuppressive drug that has been used in human transplants and autoimmune diseases, and it has been approved for use in dermatology for many years.

Who Is on the Research Team?

CH

Christopher H Lieu

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Serum albumin >= 2.5 g/dl
My cancer can be measured using specific criteria.
My advanced cancer does not respond to standard treatments or no standard treatment exists.
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Exclusion Criteria

Patients with hyponatremia (sodium < 130 mmol/L)
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.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive selumetinib and cyclosporine orally in a dose-escalation study. Selumetinib is given twice daily starting on day -7 of course 1, and cyclosporine is given twice daily starting on day -3 of course 1. Both drugs are then administered on days 1-28 of each 28-day cycle.

28 days per cycle
Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including assessment of adverse events and progression-free survival.

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclosporine
  • Selumetinib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (selumetinib and cyclosporine)Experimental Treatment4 Interventions

Cyclosporine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Neoral for:
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Approved in United States as Neoral for:
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Approved in Canada as Neoral for:
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Approved in Japan as Neoral for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
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