Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prologue Research International | INDUSTRY |
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-5013 | Drug | |||
| liposomal doxorubicin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca | ||
| Phase II-To explore the anti-tumor activity of the combination of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days when given to subjects with advanced ovarian or primary peritoneal carcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I-To explore the anti-tumor activity of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma. | ||
| Phase II-To evaluate the safety profile of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma |
Not provided
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 > or = to 1 years.
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) allergic reaction/hypersensitivity to thalidomide.
Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
Subjects who have received > 200mg/m2 of anthracycline or anthracendione either alone or in combination. (Additional caution must be taken in subjects with mediastinal radiation.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94115 | United States | ||
| MD Anderson Cancer Center Orlando |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32806 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| 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 |
Not provided
Not provided