Completed

Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

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

Sorafenib (Nexavar, BAY43-9006)

+ Placebo
Drug
Who is being recruted

Carcinoma, Renal Cell

Over 18 Years
+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: September 2002

See protocol details

Summary

Principal SponsorBayer
Last updated: December 19, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2002Actual date on which the first participant was enrolled.

The purpose of the study is to: * Find out if BAY 43-9006 prevents the growth of tumors * For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. * Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. * Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Official TitleRandomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer. 
Principal SponsorBayer
Last updated: December 19, 2014
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
501 patients to be enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Carcinoma, Renal Cell
Criteria
10 inclusion criteria required to participate
Age > 18 years- Patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable
Patients with non-colorectal cancers are eligible and must be progressing at the time of the screening assessment and for whom no other treatment exists
Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria - Histological or cytological documentation of cancer- ECOG Performance status 0 or 1
Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function (assessed by the following laboratory requirements)

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21 exclusion criteria prevent from participating
Patients who meet the following criteria at the time of screening will be excluded
Non small cell lung cancer, hepatocellular cancer, CML and AML
Serious cardiac arrhythmia
Congestive Heart Failure (NYHA Class 3 or 4)

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Study Plan

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

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Placebo
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 7 locations
Suspended
Unknown FacilityChicago, United StatesSee the location
Suspended
Unknown FacilityPhiladelphia, United States
Suspended
Unknown FacilityHouston, United States
Suspended
Unknown FacilitySan Antonio, United States
Completed7 Study Centers