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Study in two stages, and with a sub-study.
Stage A: To determine efficacy of lenalidomide as single agent in patients with recurrent ovarian cancer in second or third line.
Stage B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin.
Substudy: To investigate the impact of the lenalidomide on patients' immune system affected by cancer and to look for an immunizing marker which could be predictive of the activity of the lenalidomide in the solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenalidomide | Experimental | Phase II: lenalidomide 20 mg/day in continuous regimen. Phase I: lenalidomide 25 mg/day 21 days/28 + carboplatin AUC 5 + caelyx 30 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin | STAGE A: To determine efficacy of lenalidomide as single agent in patients with recurrent ovarian cancer in second or third line. STAGE B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin. | Rate of Tumor Response + Stable Disease (at 4 months) / DMT |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of lenalidomide as single agent, then in combination | STAGE A:
STAGE B:
| Response rate, Stable Disease rate at 4 months / MDT |
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Inclusion Criteria:
Stage A: Patient:
Stage B: Patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric SELLE, MD | Hôpital Tenon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Tenon | Paris | 75020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25210017 | Derived | Selle F, Sevin E, Ray-Coquard I, Mari V, Berton-Rigaud D, Favier L, Fabbro M, Lesoin A, Lortholary A, Pujade-Lauraine E. A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma. Ann Oncol. 2014 Nov;25(11):2191-2196. doi: 10.1093/annonc/mdu392. Epub 2014 Sep 10. |
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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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| 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 |