A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl versus Placebo Concurrently with Pemetrexed (Alimta) as Second-Line Therapy in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer - ND
- Conditions
- Patients with locally advanced or metastatic NSCLC (Stage IIIA, IIIB, or IV) that is not amenable to curative therapy.MedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV
- Registration Number
- EUCTR2006-006698-25-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
[1] Histologic or cytologic diagnosis of NSCLC with locally advanced or metastatic disease (Stage IIIA, IIIB or IV at entry) that is not amenable to curative therapy per the American Joint Committee on Cancer Staging Criteria for Lung Cancer [2] Patients must have progressive disease after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease. Prior chemotherapy given as neoadjuvant or adjuvant therapy for early stage disease, completed at least 12 months prior to the diagnosis of advanced stage disease, will not be counted as a prior regimen. Previous treatment with bevacizumab or other targeted agents is permitted, provided that the targeted agent was initiated concurrently with chemotherapy as part of first-line treatment. [3] At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines [4] Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale [5] Previous radiation therapy (including thoracic radiation) allowed to 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to enrollment (except for alopecia). Prior radiotherapy must be completed at least 2 weeks prior to enrollment. Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. [6] Adequate organ function including the following: Adequate bone marrow reserve: white blood cell (WBC) count >=3.0 × 109/L, absolute neutrophil count (ANC) >=1.5 × 109/L, platelet count >=100.0 × 109/L and hemoglobin >=9.0 g/dL (>=5.6 mmol/L). Hepatic: bilirubin <=1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) <=2.5 × ULN, or <=5 × ULN with liver metastases. Renal: serum creatinine <1.5 ULN and calculated creatinine clearance (CrCl) >=45 mL/min based on the standard Cockcroft and Gault formula [10] Written informed consent.
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] Previous treatment with enzastaurin or pemetrexed. [2] Recent (within 30 days of enrollment) or concurrent yellow fever vaccination. [3] Serious cardiac condition, such as myocardial infarction within 6 months, angina, abnormal ECG indicative of cardiac disease, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment JCBT.8). Patients with a QTc prolongation >450 msec (males) or >470 msec (females) and patients who have a congenital long-QT-syndrome in their own medical history or family medical history should be excluded. [4] Central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before study enrollment). A screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment, in the absence of a clinical suspicion of brain metastases, is not required. [5] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <= 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [6] Inability to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Section 5.7).
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