Randomized, multicenter, double-blind, phase 3 trial of Tavocept versus Placebo in patients with newly diagnosed or relapsed advanced (stage IIIB/IV) primary adenocarcinoma of the lung treated with docetaxel or paclitaxel plus cisplati
- Conditions
- ewly diagnosed or relapsed advanced (Stage IIIB/IV) primary adenocarcinoma of the lungMedDRA version: 9.1Level: LLTClassification code 10025031Term: Lung adenocarcinoma
- Registration Number
- EUCTR2009-012983-14-HU
- Lead Sponsor
- BioNumerik Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 575
1. Patients with confirmed histopathological or cytological diagnosis of inoperable
advanced (stage IIIB/IV) primary adenocarcinoma (including bronchioalveolar
cell carcinoma) of the lung.
2. All patients must have documented stage IIIB disease with malignant pleural or
pericardial effusions or stage IV disease.
3. Patients may have newly diagnosed or recurrent/relapsed disease.
4. No form of any prior systemic treatment for non-small cell lung cancer, including
chemotherapy, immunotherapy (e.g., monoclonal antibodies, vaccines), hormonal
therapy (excluding dexamethasone or corticosteroids), targeted therapies (including EGFR inhibitors), or investigational drugs.
5. Prior radiation therapy is allowed, provided that at least one (1) area of
measurable (by CT scan) or evaluable disease by RECIST (Version 1.1) that has
not been subject to prior irradiation.
6. Prior prophylactic cranial irradiation (PCI) or radiation therapy are allowed provided that any such therapy is completed and any radiation-induced sequelae
are recovered at least 21 days before receiving study treatment.
7. Patients with an ECOG performance status of 0 or 1.
8. Patients who are at least 18 years of age.
9. Patients with documented stable CNS metastases with no cognitive deficits, or
progressive sensory or motor deficits or seizures during the last 21 days are
eligible. Patients must have discontinued anti-seizure medications and steroids at
least 21 days prior to patient randomization.
10. Patients must have fully recovered from any prior major surgical or diagnostic
staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative
status of at least 30 days.
11. Patients must have adequate bone marrow, adequate hepatic function, and a
baseline serum creatinine level documented by specific laboratory criteria:
• Absolute neutrophil count (ANC) = 1.5 × 109/L
• Hemoglobin = 10 g/dL
• Platelet count = 100 × 109/L
• Total bilirubin < the upper limit of normal (ULN)
• Aspartate aminotransferase (AST/SGOT) = 1.5 × ULN
• Alanine aminotransferase (ALT/SGPT) = 1.5 × ULN
• Alkaline phosphatase = 2.5 × ULN
• Baseline serum creatinine level no greater than 1.5 mg/dL or 133 µmol/L.
• Magnesium = 1.7 mg/dL
12. Female patients of child-bearing potential must have a negative pregnancy test,
and must agree to use an acceptable contraceptive method during the study. Male
patients with partners of child-bearing potential must also agree to use an adequate
method of contraception.
13. Patients must have been disease-free at least 2 years for other malignancies,
excluding:
• Prior surgical resection of primary adenocarcinoma of the lung that occurred
more than one year prior to randomization,
• Curatively-treated basal cell carcinoma,
• Squamous cell carcinoma of the skin, or
• Carcinoma in situ of the cervix.
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. Patients with small cell, squamous cell, large cell, or undifferentiated, or any form
of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma)
histopathological or cytological diagnosis of primary lung cancer.
2. Stage IIIB disease without malignant pleural or pericardial effusions, or Stage IIIIA
disease.
3. Patients with adenocarcinoma arising from any primary sites other than the lung.
4. Patients with recent onset (within 6 months of randomization) of congestive heart
failure (New York Heart Association Classification Class II or greater), angina
pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia,
myocardial infarction, stroke, or transient ischemic attacks.
5. Patients with unstable CNS metastases (characterized by progressive
sensory/motor impairment, cognitive/speech impairment, or seizure activity
within 21 days of initial study treatment.
6. Patients who do not have at least one (1) measurable or non-measurable but
assessable disease site that has not been previously irradiated.
7. Patients who are known to be HIV-positive.
8. Patients with active infections (including viral, fungal, bacterial, rickettsial,
mycobacterial, or parasitic), uncontrolled high blood pressure, uncontrolled
diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the
last 6 months, or other serious underlying medical condition.
9. Patients with documented hypersensitivity to any of the study medications or
supportive agents that may be used.
10. Patients who are pregnant or are breastfeeding.
11. Patients with a life expectancy of less than 5 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the co-administration of Tavocept with first-line combination chemotherapy (paclitaxel or docetaxel plus cisplatin) as compared to placebo can result in a significant increase in overall survival in the defined patient population.<br>;Secondary Objective: To determine if Tavocept co-administration concurrently prevents and/or mitigates cisplatin-induced renal toxicity and other common chemotherapy-induced toxicities, including anemia and emesis in patients.<br>;Primary end point(s): The primary endpoint is overall survival (OS); defined as the time period from the date of patient randomization to the date of death due to any cause.<br>
- Secondary Outcome Measures
Name Time Method