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CancerPhase 2NCT00101413

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Cancer and Carcinoma, Non-Small Cell Lung, run by Bayer at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer. If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Carcinoma, Non-Small Cell Lung
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesin 2 countries
Study dates
Apr 2004to Apr 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age = 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Life expectancy of at least 12 weeks at the pre-treatment evaluation
  • Patients with metastatic, measurable, histologically or cytologically documented NSCLC (includes squamous, large cell or adenocarcinoma). In case of unique metastatic site, histological confirmation is required in order to ensure proper diagnosis prior to study entry
  • Patients must have progressive non-small cell lung cancer (NSCLC)
  • No more than 2 prior systemic agent or regimen at least 28 days prior to study entry. (Prior therapy with gefitinib is allowed but not mandatory)
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  • Patients must be considered appropriate for systemic anti-cancer therapy by the Investigator
  • Patients with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Adequate bone marrow, liver and renal function, as assessed by the following laboratory:
  • Hemoglobin = 9.0 g/dl
  • Absolute granulocytes = 1.5 x 10E9/L
  • Platelet count = 100 x 10E9/L
  • Total bilirubin < 1.5 x the upper limit of normal
  • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • prothrombin time (PT) or International Normalized Ratio (INR) and partial thromboplastin time (PTT) < 1.5 x upper limit of normal (except in patients who are on warfarin or heparin. Patients who receive anti-coagulation treatment with an agent such as warfarin or heparin, prophylactically or therapeutically, will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care)
  • Serum creatinine = 2.0 x upper limit of normal
  • Amylase and lipase < 1.5 x the upper limit of normal

Who cannot join

  • Cardiac arrhythmia requiring anti-arrhythmics (excluding beta-blockers or digoxin), symptomatic coronary artery disease (CAD) or ischemia (myocardial infarction (MI) within the last 6 months) or congestive heart failure (CHF) > New York Heart Association (NYHA) Class II
  • Uncontrolled hypertension
  • Complete renal shut-down requiring hemo- or peritoneal dialysis
  • Mixed histologies
  • Active clinically serious infections (> grade 2 on the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0)
  • Known history of HIV infection or chronic hepatitis B or C
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  • Known 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. A head CT or MRI must be conducted to rule out brain metastasis or meningeal tumors. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided that the dose is stable for one month prior to and following screening radiographic studies)
  • History of seizure disorder requiring medication (such as steroids or anti-epileptics)
  • History of organ allograft and bone marrow transplant
  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis \& T1] or other malignancies curatively treated > 3 years prior to entry)
  • Patients with clinically significant bleeding (e.g., gastrointestinal bleeding) within the past month prior to study entry are ineligible
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (e.g. cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between BAY 43-9006 and oral contraceptives
  • Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patients participation in the study or evaluation of the study results
  • Known allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment
  • Anti cancer chemotherapy, immunotherapy, vaccines or investigational therapy during the study or within 4 weeks of study entry.
  • Radiotherapy during the study or within 4 weeks of study entry. Patients must have recovered from radiation-induced toxicity. However, palliative is allowed for local pain control.
  • Any surgical procedure within 4 weeks prior to the start of study drug. Autologous and/or allogenic including mini-allogenic bone marrow transplant or stem cell rescue. Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (GM-CSF), during or within 3 weeks of study entry. G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity, when medically indicated, or at the discretion of the investigator. Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study. Use of St. John's Wort. Use of rifampicin. Prior use of Raf-Kinase inhibitors, MAPK/ERK kinase (MEK) or Farnesyl Transferase Inhibitors. Prior use of Bevacizumab and all other drugs that target vascular endothelial growth factor (VEGF)/ vascular endothelial growth factor receptor (VEGFR). Use of any investigational drug therapy outside of this during or within 4 weeks of study entry.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Study site

    Houston, Texas, 77030

Other trials in United States

Germany1 site

  • Study site

    Großhansdorf, Schleswig-Holstein, 22927

Other trials in Germany

About this study

Official title: A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Patients With Relapsed or Refractory Advanced Non-small Cell Lung Carcinoma

The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.

  • If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
  • If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
  • If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.
Read the detailed description

In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters.

Issues on safety are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section:

  • gastrointestinal (GI)
  • not otherwise specified (NOS)
  • central nervous system (CNS)
  • National Cancer Institute Common Terminology Criteria (NCI-CTC)
  • Medical Dictionary for Regulatory Activities (MedDRA)
  • System Organ Class (SOC)
  • interim analysis (IA)
Being tested
Sorafenib (Nexavar, BAY43-9006)
Keywords
NSCLC
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

    BAY43-9006 400 mg bid X 28 day cycles [Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.

Study groups in NCT00101413
Study groupRoleWhat they receive
SorafenibExperimentalSorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)

    CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- >=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- >=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- >clinically meaningful cancer-related deterioration as judged by the investigator.

    Measured: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.

Secondary outcomes (4)

  1. Duration of Stable Disease

    Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.

    Measured: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.

  2. Overall Survival

    Overall survival was calculated from the date of the first treatment until death of the subject.

    Evaluation by Kaplan-Meier methodology, descriptive analysis.

    Measured: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.

  3. Percentage of Subjects With Stable Disease (SD)

    Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.

    Measured: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.

  4. Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)

    HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.

    Measured: From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionJun 2005
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101413
Sponsor's protocol ID
100557
Status last verified
Sep 2013
First submitted
10 Jan 2005
Last updated
30 Oct 2013
Data monitoring committee
No

Publications

  • Blumenschein GR Jr, Reck M, Fossella F, Stewart DJ, Lathia C, Pena C. Plasma biomarkers correlating with clinical outcome in a phase II study of sorafenib in advanced NSCLC. Cancer Biomark. 2011-2012;10(6):287-98. doi: 10.3233/CBM-2012-0253.

    PubMed 22820084

  • Blumenschein GR Jr, Gatzemeier U, Fossella F, Stewart DJ, Cupit L, Cihon F, O'Leary J, Reck M. Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non-small-cell lung cancer. J Clin Oncol. 2009 Sep 10;27(26):4274-80. doi: 10.1200/JCO.2009.22.0541. Epub 2009 Aug 3.

    PubMed 19652055

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Cancer and Carcinoma, Non-Small Cell Lung, run by Bayer at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC) (time frame: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101413, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.

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