NCT00079612

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2002

Typical duration for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

First QC Date

March 9, 2004

Last Update Submit

December 18, 2014

Conditions

Carcinoma, Renal Cell

Keywords

Renal Cell CancerRCCCancer

Outcome Measures

Primary Outcomes (1)

  • Number of progressions post randomization to placebo or sorafenib

    12 weeks post randomization

Secondary Outcomes (3)

  • Time to progression

    Until Progression occurs

  • Duration of objective tumor response

    Time from initial Response to documented Tumor Progression

  • Overall survival time

    At the End-of-Study visit

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Sorafenib (Nexavar, BAY43-9006)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

800mg daily (2x 400mg tabs)

Arm 1
PlaceboDRUG

2x 400mg tabs daily

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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):
  • Hemoglobin \>/= 9.0 g/dl - Absolute neutrophil count (ANC) \>/=1,500/mm3
  • Platelet count = 100,000/µl3
  • Total bilirubin \</=1.0 times the upper limit of normal unless due to Gilbert's
  • ALT and AST \</= 2.5 x upper limit of normal. (For patients with hepatic involvement of their cancer, ALT and AST \< 5.0 x upper limit of normal)
  • PT-INR/PTT \< 1.5 x upper limit of normal. (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
  • In addition, these patients must be monitored with weekly coagulation assessments throughout the Run-in Period)- Serum creatinine \< 1.5 x upper limit of normal

You may not qualify if:

  • 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)
  • Active of coronary artery disease or ischemia
  • Active acute infections that could be worsened by anticancer therapy or interfere with this study
  • Known HIV infection
  • Metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
  • Patients currently receiving medication (steroid or anticonvulsant therapy) for seizure disorder
  • History of organ allograft- Previous or concurrent cancer that is distinct from the cancer being evaluated in this study. Several situations are excluded, including cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors or any cancer definitively treated greater than 3 years
  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
  • Radiotherapy during the study or within 3 weeks prior to the first dose of study drug
  • Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of study drug
  • Biological response modifiers, such as G-CSF within 3 weeks prior to study entry
  • Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

London, Greater London, SW3 6JJ, United Kingdom

Location

Unknown Facility

Glasgow, Strathclyde, G11 6NT, United Kingdom

Location

Unknown Facility

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2004

First Posted

March 11, 2004

Study Start

September 1, 2002

Study Completion

January 1, 2007

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

US(4)GB(3)