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Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

NCT02560012 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-10-12

Study results available
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Summary

This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and two for second-line therapy. Each of these drugs targets a specific molecular pathway. At present oncologists select therapy based on current guidelines. There is a new method for trying to use biomarker information from the subject's tumor to select the best drug to treat the subject. This process is investigational, which is why this study is being done.

Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. These biomarkers build a tumor profile or "fingerprint" of the subject's tumor. A new focus in cancer care is personalized treatment, where doctors select a drug based on the subject's tumor's unique "fingerprint" which is more likely to be effective in fighting the tumor. Selecting the treatment the subject is more likely to respond to requires a thorough understanding of the relationship between biomarker and treatment effect. The PI wants to gather data to understand that relationship to help treat future cancer patients. The purpose of this study is to evaluate efficacy of treatments that are selected based on tumor profiles.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sunitinib

One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off

DRUG

Temsirolimus

25 mg by an IV infusion over 30-60 minutes, once a week

DRUG

Sorafenib

400 mg (2 tablets) orally twice daily without food

DRUG

Pazopanib

800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal

DRUG

Everolimus

10 mg orally once daily with or without food

DRUG

Axitinib

5 mg orally twice daily

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Robert Amato, DO · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-04
Primary Completion
2017-07-27
Completion
2017-07-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560012 on ClinicalTrials.gov