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Tyrosine Kinase Inhibitor
Cediranib + Selumetinib for Cancer
Phase 1
Waitlist Available
Led By Brian A Costello
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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, cediranib maleate and selumetinib sulfate, in treating patients with solid malignancies. These drugs may stop the growth of tumor cells by blocking enzymes needed for cell growth or by blocking blood flow to the tumor.
Who is the study for?
This trial is for patients with solid tumors, including melanoma, who have no standard curative therapy available. Participants must have a certain level of blood cells and organ function, be able to consent, and not be pregnant or nursing. They should also agree to use contraception and return for follow-up visits.Check my eligibility
What is being tested?
The study is testing the combination of two drugs, Cediranib Maleate and Selumetinib Sulfate, to see if they can halt tumor growth by blocking enzymes needed for cell growth or cutting off the tumor's blood supply. The trial aims to find the safest doses with the least side effects.See study design
What are the potential side effects?
Potential side effects may include high blood pressure, heart issues like failure or arrhythmia, bleeding episodes or coughing up blood (hemoptysis), protein in urine indicating kidney problems, fatigue from low hemoglobin levels (anemia), liver enzyme changes suggesting liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Best response
Incidence of adverse events, classified as either possibly, probably, or definitely related to study treatment
Incidence of hematologic toxicities
+2 moreOther outcome measures
Changes of the serum levels of M30 (dose expansion phase)
Changes of the serum levels of caspase 3 (dose expansion phase)
Changes of the serum levels of cytochrome c (dose expansion phase)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cediranib maleate, selumetinib)Experimental Treatment6 Interventions
Patients receive cediranib maleate PO QD and selumetinib sulfate PO QD or BID on days 1-28 (days 8-28 of cycle 1). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles may be extended to 12 weeks after 1 year of study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Cediranib Maleate
2010
Completed Phase 2
~660
Selumetinib Sulfate
2017
Completed Phase 2
~80
Cediranib
2016
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,134 Total Patients Enrolled
557 Trials studying Melanoma
193,214 Patients Enrolled for Melanoma
Brian A CostelloPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate in this study if you are pregnant, breastfeeding, not using birth control, have certain medical conditions, are currently taking certain medications, have certain laboratory test results, have certain medical history, or have had certain medical procedures recently.I haven't had certain cancer treatments in the last 28-42 days and have recovered from their effects.You have uncontrolled high blood pressure, severe heart failure, fast irregular heart rate, recent heart attack or angina, or untreated brain or central nervous system tumors.My cancer cannot be surgically removed and there's no standard treatment for it.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I agree to give blood samples and my stored tumor tissue for research.Your alkaline phosphatase level should be within a certain range based on the blood test taken within the last three weeks.You are expected to live for at least 12 more weeks.I am a woman who can have children and have a recent negative pregnancy test.Your bilirubin levels are not higher than 1.5 times the upper limit of normal.Your white blood cell count is at least 1500 per microliter.I am fully active or have some restrictions but can still care for myself.My cancer can be measured by tests or seen on scans.Your platelet count is at least 100,000 per microliter within the last 21 days before joining the study.Your liver enzyme levels are not too high, unless you have liver metastases, in which case they can be a little higher but still within a certain limit.Your kidney function test result must be within a certain range.There is a known treatment for my condition that could cure me or extend my life.My kidney function, measured by creatinine clearance, is good.Your hemoglobin level is at least 9.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cediranib maleate, selumetinib)
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.
How many human participants are enrolled in this clinical experiment?
"Currently, this medical trial is not admitting any further patients. It was first announced on the 25th of May 2011 and last revised on the 20th of September 2022. There are presently 3051 clinical trials for malignant neoplasms that have open spaces, including 118 studies regarding Cediranib Maleate."
Answered by AI
Is enrolment for this experiment open at the present time?
"This research project is no longer accepting patients. It was initially listed on May 25th 2011 and the listing was last updated in September 20th 2022. If you are seeking other medical trials, there are currently 3051 actively recruiting individuals with malignant neoplasms and 118 studies looking for participants that can take Cediranib Maleate."
Answered by AI
Has Cediranib Maleate been given a greenlight by the Food and Drug Administration?
"Our team at Power has assigned Cediranib Maleate a score of 1 on our safety scale due to Phase 1 trial data, which indicates limited evidence for efficacy and safety."
Answered by AI
Are there any preceding experiments involving Cediranib Maleate?
"Cediranib Maleate was first studied in 2004 at Bronson Methodist Hospital, and since then 745 trials have been concluded. Currently there are 118 new studies underway, with many of them being conducted out of Rochester, Minnesota."
Answered by AI
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