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| Name | Class |
|---|---|
| Prologue Research International | INDUSTRY |
Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-5013 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer. |
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Inclusion Criteria:
WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.
Exclusion Criteria:
Any of the following laboratory abnormalities:
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year.
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Prior > or = grade 3 allergic reaction/hypersensitivity to thalidomide.
Prior > or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
Prior use of lenalidomide.
Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Rush Cancer Institute |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Cancer and Blood Institute | Metairie | Louisiana | 70006 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |