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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

~5640

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,628 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,000 Total Patients Enrolled

Vivek SubbiahPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

186 Total Patients Enrolled

Media Library

Everolimus (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01582191 — Phase 1

Cancer Research Study Groups: Treatment (vandetanib, everolimus)

Cancer Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT01582191 — Phase 1

Everolimus (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01582191 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety parameters have been established for this pharmacological research?

"The safety of this pharmacological study was judged to be a 1 due to it being in the initial testing stage, with limited data on its efficacy and security."

Answered by AI

Is this a revolutionary clinical trial?

"Currently, 102 trials are being conducted across 1302 cities and 49 different nations regarding Pharmacological Study. The inaugural study began in 2006 courtesy of Genzyme, a Sanofi Company; it was Phase 3 with 437 participants. In the intervening years since then, 1051 investigations have been concluded successfully."

Answered by AI

What evidence-based treatments are explored through Pharmacological Study?

"Pharmacological Study has proven to effectively combat malignant neoplasms, transplant rejection, kidney issues, and even Waldenstrom Macroglobulinemia."

Answered by AI

Is recruitment for this experiment still ongoing?

"Per clinicaltrials.gov, this medical experiment is presently recruiting subjects. This investigation was initially advertised on May 14th 2012 and has received updates as recently as June 29th 2022."

Answered by AI

How many individuals are being chosen for inclusion in this clinical experiment?

"Correct. Clinicaltrials.gov indicates that this medical experiment is actively seeking participants, with the initial posting occurring on May 14th 2012 and an edit as recent as June 29th 2022. The study aims to enroll 174 patients across a single site."

Answered by AI

Recent research and studies

Lung CancerJournal

Systemic and CNS Activity of the RET Inhibitor Vandetanib Combined with the Mtor Inhibitor Everolimus in KIF5B-RET Re-arranged Non-small Cell Lung Cancer with Brain Metastases

Subbiah, Vivek, Jenny Berry, Michael Roxas, Nandita Guha-Thakurta, Ishwaria Mohan Subbiah, Siraj M. Ali, Caitlin McMahon, et al.. 2015. “Systemic and CNS Activity of the RET Inhibitor Vandetanib Combined with the Mtor Inhibitor Everolimus in KIF5B-RET Re-arranged Non-small Cell Lung Cancer with Brain Metastases”. Lung Cancer. Elsevier BV. doi:10.1016/j.lungcan.2015.04.004.

clinicaltrials.govStudy

Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

2012. "Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01582191.

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