Featured Clinical Trial:

Non-small cell lung cancer (product/compound: ASA404; Docetaxel)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status: Enrollment closed.

Condition: Non-Small Cell Lung Cancer

Product Name/Compound: ASA404; Docetaxel

Full Study Title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-small Cell Lung Cancer (NSCLC)

Study Summary: Study to determine if adding ASA404 to Docetaxel chemotherapy makes cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

Eligible Participants:

Inclusion (Eligible):

• Histologically confirmed non-small cell carcinoma of the lung of all histologies.
• Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
• Age ≥18 years old
• Acceptable organ functions

Exclusion (Not Eligible):

• Patients having CNS metastases. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed.
• Patients with concurrent malignancy, or history or prior malignancy within the past two years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer.
• Radiotherapy ≤2 weeks prior to randomization. Patients must have recovered from all acute radiotherapy-related toxicities.
• Major surgery must be completed 4 weeks prior to starting study treatment.
• Treatment with all prior anticancer therapies ≤3 weeks prior to randomization (≤6 weeks for bevacizumab, mitomycin and nitrosoureas)
• Prior treatment with docetaxel for NSCLC in the locally advanced or metastatic first-line setting
• Prior treatment with VDAs or tumor - VDAs
• Any medical condition resulting in ≥CTC grade 2 dyspnea
• Patients with systolic BP >160 mm Hg and/or diastolic BP >90 mm Hg while on medication for hypertension
• Patients with recent hemoptysis associated with NSCLC (>1 teaspoon in a single episode within 4 weeks)
• Patients with any one of the following:
  • Patients with long QT syndrome
  • Patients with a Baseline 12-lead ECG QTcF of >450 msec for men or >470 msec for women using the Fridericia [QTcF formula] measurement determined per central ECG evaluation report
  • Congestive heart failure (NY Heart Association class III or IV)
  • Patients with a myocardial infarction within 12 months of starting study treatment or with implanted cardiac pacemaker
  • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
  • History of poorly-controlled hypertension or poor compliance with anti-hypertensive regimen
  • History of a sustained ventricular tachycardia
  • Presence of atrial tachycardia (e.g., atrial fibrillation, atrial flutter, multifocal atrial tachycardia, supraventricular tachycardia) if not effectively rate-controlled
  • History of ventricular fibrillation or Torsades de Pointes (TdP)
  • Right bundle branch block (RBBB) and either left anterior hemiblock or left posterior hemiblock (bifasicular block)
  • Bradycardia defined as heart rate < 50 beats per minute
• Patients who are currently receiving treatment with any medications that have the potential to prolong QT interval or are known to have a risk of causing Torsades de Pointes
• Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80
• Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
• Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
• Significant neurologic or psychiatric disorder which could compromise participation in the study
• Patients receiving full-dose therapeutic oral or parenteral anticoagulation are ineligible. Patients receiving thrombolytic therapy within 10 days of starting are also ineligible

Study Phase: Phase III (What are Phases?)

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Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT00738387

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