Selumetinib + Cyclosporine for Colorectal Cancer

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Steroids, Anticonvulsants, Antiarrhythmics

Disqualifiers: Recent chemotherapy, Brain metastases, Cardiac conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

40 Participants Needed

Trial Summary

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.

Research Team

Christopher H Lieu

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment (selumetinib and cyclosporine) Experimental Treatment 4 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.

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

Approved in European Union as Neoral for:

• Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
• Treatment of severe psoriasis
• Treatment of nephrotic syndrome

Approved in United States as Neoral for:

• Prevention of organ rejection in kidney, liver, and heart transplants
• Treatment of severe rheumatoid arthritis
• Treatment of severe psoriasis

Approved in Canada as Neoral for:

• Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
• Treatment of severe psoriasis
• Treatment of nephrotic syndrome

Approved in Japan as Neoral for:

• Prevention of organ rejection in kidney, liver, and heart transplants
• Treatment of severe rheumatoid arthritis
• Treatment of severe psoriasis

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+