EUCTR2010-022240-21-HU
Active, not recruiting
Not Applicable
A Phase 1b/2 Study of Carboplatin-Paclitaxel, with or without ISIS 183750 (an eIF4E Inhibitor), in Patients with Stage IV Non-Small Cell Lung Cancer
Isis Pharmaceuticals Inc.0 sites118 target enrollmentMay 31, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Isis Pharmaceuticals Inc.
- Enrollment
- 118
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with Stage IV NSCLC are eligible to be included in the study only if they meet all of the following
- •1\. Provide written informed consent prior to screening.
- •2\. Male or female patients, age \= 18 years.
- •3\. Histologically or cytologically confirmed diagnosis of NSCLC.
- •4\. Stage IV disease (including patients with pleural effusion who were previously classified as Stage IIIB).
- •5\. All of the following if patient has had prior radiation therapy:
- •a. Lesion(s) used for determination of response were not previously irradiated or have increased in size since the
- •completion of radiotherapy
- •b. The patient has recovered from any acute effects of the radiotherapy
- •c. Radiotherapy was completed at least 4 weeks prior to Screening.
Exclusion Criteria
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1\. Part 1: More than 2 prior chemotherapy or biological therapy regimens (approved or experimental) for
- •NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive
- •cycles of treatment.
- •Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant
- •and neoadjuvant treatments
- •2\. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological
- •agents) before Screening or 5 half\-lives of study agent, whichever is longer
- •3\. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is
- •required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
Outcomes
Primary Outcomes
Not specified
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