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

Phase 2
18 Years
Not Enrolling
Cancer, Carcinoma, Non-Small Cell Lung

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Trial Information

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

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)

Inclusion Criteria:

- 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)

- Patients must be considered appropriate for systemic anti-cancer therapy by the

- 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

- 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

Exclusion Criteria:

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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)

Outcome Description:

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.

Outcome 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.

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

April 2008

Related Keywords:

  • Cancer
  • Carcinoma, Non-Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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