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| Name | Class |
|---|---|
| Prologue Research International | INDUSTRY |
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-5013 | Drug | |||
| topotecan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I-To determine the MTD and evaluate the safety profile of oral lenalidomide and topotecan | ||
| Phase II-To explore the anti-tumor activity based on objective response rate (CR + PR) of the combination of oral lenalidomide and topotecan |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I-To explore the anti-tumor activity based on response of the combination of lenalidomide and topotecan. | ||
| Phase II-To explore the safety profile of the combination of lenalidomide and topotecan |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > 1 year.
Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
More than 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
Concurrent use of any other anti-cancer agents.
Any prior use of lenalidomide.
Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
Known active Hepatitis C.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of GeorgiaDept of OBGYN | Augusta | Georgia | 30912-3335 | United States | ||
| University of MinnesotaObstetrics & Gynecology, MMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21556801 | Background | Carter JS, Downs LS Jr. A prospective clinical trial of lenalidomide with topotecan in women with advanced epithelial ovarian carcinoma. Int J Clin Oncol. 2011 Dec;16(6):666-70. doi: 10.1007/s10147-011-0243-1. Epub 2011 May 10. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |