← Back to Search

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

Must not have

Cardiac conditions as follows: Uncontrolled hypertension (blood pressure [BP] >= 150/95 despite optimal therapy), Heart failure New York Heart Association (NYHA) class II or above or left ventricular ejection fraction < 50%, Atrial fibrillation with heart rate > 100 beats per minute (bpm), Unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly), Patients who require concomitant agents that prolong corrected QT interval (QTc), Known brain or central nervous system (CNS) metastases without definitive therapy; patients who have received definitive therapy for CNS lesions may be considered if there is no evidence of progression on computed tomography (CT) or magnetic resonance imaging (MRI) imaging obtained 3 months apart

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

There is a known treatment for my condition that could cure me or extend my life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Best response

Incidence of adverse events, classified as either possibly, probably, or definitely related to study treatment

Incidence of hematologic toxicities

+2 more

Other study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2080

Cediranib Maleate

2010

Completed Phase 2

~660