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Kinase Inhibitor

Vandetanib + Everolimus for Advanced Cancer

Phase 1

Waitlist Available

Led By Vivek Subbiah

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be at least 3 weeks beyond their previous cytotoxic chemotherapy

Patients must have organ and marrow function defined as: Absolute neutrophil count more or equal to 750/mL; platelets more or equal to 50,000/mL; creatinine less or equal to 3x ULN; total bilirubin less than or equal to 3.0

Must not have

Presence of a symptomatic bradyarrhthmia or uncompensated heart failure

Congenital long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of two drugs when given together to treat patients with cancer that has spread. The drugs may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for patients with advanced or metastatic cancer that's resistant to standard therapy, relapsed, or without a survival-improving standard option. They must be weeks past prior treatments, have adequate organ/marrow function and agree to use contraception. Exclusions include certain heart conditions, uncontrolled illnesses, pregnancy/lactation, and hypersensitivity to the drugs tested.

What is being tested?

The study tests combining vandetanib and everolimus in patients with widespread cancer. It aims to find the safest dose while observing how these drugs might halt cancer cell growth by inhibiting key enzymes necessary for their proliferation.

What are the potential side effects?

Potential side effects may include issues related to enzyme inhibition affecting cell growth which could lead to fatigue, digestive problems, skin reactions and possibly impact blood counts leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been over 3 weeks since my last chemotherapy.

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My blood counts and kidney and liver functions are within the required ranges.

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I am capable of limited self-care and spend more than half of my waking hours out of bed.

Exclusion Criteria

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

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I have a slow heartbeat or heart failure that affects my daily life.

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I have a genetic heart condition known as long QT syndrome.

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My heart's QT interval is over 500 ms and cannot be corrected.

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I do not have any uncontrolled illnesses like infections or asthma.

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I have had a stroke in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anti-tumor efficacy of the combination in terms of response rate

Area under the serum concentration-time curve (AUC)

Maximum observed serum concentration (Cmax)

+3 more

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 (vandetanib, everolimus)Experimental Treatment4 Interventions

Patients receive vandetanib PO QD and everolimus PO QD on days 1-28. Cycles 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

Everolimus

2010

Completed Phase 4

~1510

Vandetanib

2007

Completed Phase 3

~5790