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A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease


Inclusion Criteria:



- Ability to understand and willingness to sign a written Informed Consent

- Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must
have been confirmed cyto-/ histologically

- Patients must have measurable or non-measurable disease

- At least two but not more than three prior standard treatment regimens for NSCLC

- ECOG Performance Status of 0 or 1

- Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed
Consent

- Life expectancy of at least 12 weeks

- Ability to swallow oral medication

- Both men and women using adequate barrier birth control measures during the course of
the trial and 4 weeks after the completion of trial

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to start of the study
drug:

- Haemoglobin > 9.0 g/dl

- Absolute neutrophil count (ANC) >1,500/mm3

- Platelet count >/= 100,000/┬Ál

- Total bilirubin
- ALT < 2.5 x upper limit of normal ( with liver metastases) AST < 2.5 x upper limit of normal ( normal in patients with liver metastases)

- Alkaline phosphatase < 4 x upper limit of normal ( in patients with liver metastases)

- PT-INR or PTT < 1.5 x upper limit of normal

- Serum creatinine < 1.5 x upper limit of normal

- Calculated creatinine clearance of >/= 50 mL/min

Exclusion Criteria:

- NSCLC patients with predominantly squamous cell carcinoma histology

Excluded medical conditions:

- History of cardiac disease: Congestive heart failure, Active coronary artery disease
(CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE vers. 3.0)

- Uncontrolled hypertension despite two anti-hypertensive medications

- History of HIV infection or chronic hepatitis B or C

- History of organ allograft

- Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0)

- Patients with seizure disorder requiring medication

- Patients with evidence or history of bleeding diathesis or coagulopathy

- Patients undergoing renal dialysis

- Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the
first dose of the study drug

- Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to
the first dose of the study drug

- Thrombotic or embolic venous or arterial events such as cerebrovascular accident

- Pregnant or breast-feeding women.

- Any condition which could affect the absorption or pharmacokinetics of the study drug

- Prior treatment with other VEGF(R) inhibitors, including compounds that impact
vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents
[VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab
(Avastin) is permitted.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary efficacy variable is overall survival (OS).

Outcome Time Frame:

Initial assessment will be performed at baseline and every 3 weeks thereafter

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentosy Tecnologia Medica

Study ID:

13266

NCT ID:

NCT00863746

Start Date:

April 2009

Completion Date:

March 2013

Related Keywords:

  • Carcinoma
  • Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer (NSCLC)
  • Sorafenib
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fountain Valley, California  92708
Philadelphia, Pennsylvania  19104
Little Rock, Arkansas  72205-7199