Completed

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Sorafenib

Drug
Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2005
See protocol details

Summary

Principal SponsorThe Methodist Hospital Research Institute
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2005

Actual date on which the first participant was enrolled.

Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is with minimal toxicity, presents an opportunity to explore a more intensive drug administration. This study will allow individual patient titration (e,g,, intrapatient dose escalation) as per protocol. This provides the basis for the dose escalation development of sorafenib. The study is designed to evaluate the ability for patients to dose escalate. Secondary endpoints include; response, time to progression, and overall survival in patients with MRCC. Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome.

NCT00445042
Principal SponsorThe Methodist Hospital Research Institute
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

71 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal CellKidney Neoplasms

Criteria

11 inclusion criteria required to participate
Paraffin RCC tissue blocks or unstained slides must be available.
No more than one prior systemic therapy. No prior vascular endothelial growth factor receptor agents.
Histologically or cytological confirmed metastatic or unresectable clear cell renal cell carcinoma.
All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration.
Show More Criteria
10 exclusion criteria prevent from participating
No pre-existing thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication are ineligible.
No significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or recent myocardial infarction (within the last 6 months).
No patients with uncontrolled hypertension (defined as blood pressure of >160 mmHg systolic and/or > 90 mmHg diastolic on medication).
Patients with a 'currently active' second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a 'currently active' malignancy if they have completed anti-cancer therapy and are considered by their physician to be a less than 30% risk of relapse.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intrapatient dose escalation study of sorafenib

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Methodist Hospital - Baylor College of Medicine

Houston, United StatesOpen Methodist Hospital - Baylor College of Medicine in Google Maps
CompletedOne Study Center