A Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination with Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
- Conditions
- Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (AJCC) NSCLC
- Registration Number
- EUCTR2006-001990-32-GB
- Lead Sponsor
- ovelos Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 840
(1) Age = 18 years
(2) Histologically or cytologically confirmed NSCLC
(3) Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (AJCC) NSCLC
(4) ECOG performance score of 0 or 1
(5) Adequate bone marrow, hepatic, and renal function as indicated by the following parameters:
• ANC = 1,500/mm3
• Platelets = 100,000/ mm3
• AST and ALT = 2.5 x ULN, except in patients w/ documented liver metastases where it may be AST and ALT = 5.0 x ULN
• Total bilirubin = 1.5 times below the ULN
• Creatinine = 1.5 x ULN and
(6) NYHA score 1-2
(7) Life expectancy of at least 12 weeks
(8) Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during the trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
(9) The patient or patient’s legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments.
(10) The patient must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(1) Prior chemotherapy for advanced NSCLC or the patient has received prior neoadjuvant chemotherapy for NSCLC in the year prior to the date of randomization
(2) Patients with CNS metastases
(3) Any systemic disease precluding chemotherapy
(4) Chronic use of systemic corticosteroids in pharmacological doses
(5) Known or history of HIV, HBV or HCV
(6) Palliative radiation therapy within 3 weeks prior to randomization
(7) Major surgery within 3 weeks prior to randomization
(8) Myocardial infarction within the 3 months prior to randomization
(9) Peripheral neuropathy > grade 2
(10) Patient that have a splenectomy
(11) Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002
(12) Any known pre-existing medical condition, including substance abuse, that could interfere with the patient’s participation in and completion of the protocol
(13) Have received any investigational drug, defined as a drug for which there is no FDA approved indication, within the 30 days prior to randomization
(14) Pregnant female or nursing mother
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method