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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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To find out if the blood level of lenalidomide can be changed when a drug that prevents p-glycoprotein (a protein naturally present in the body that helps carry substances across cell membranes that is found in many parts of the body like the intestines, liver, and kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The study is also trying to find out if blood level of temsirolimus can be changed when a subject takes lenalidomide together with temsirolimus.
This will be a single-center, open label, 2-part study. Part 1 will be a two-period, fixed-sequence crossover study with lenalidomide alone in Period 1, followed by lenalidomide in combination with quinidine in Period 2. Part 2 will be a fixed-sequence, three-period, crossover study with lenalidomide alone in Period 1, temsirolimus (via direct intravenous infusion) in Period 2, and lenalidomide in combination with temsirolimus (via direct intravenous infusion) in Period 3. Diphenhydramine (given via intravenous injection) will be administered shortly before temsirolimus in order to decrease the chances of an allergic reaction to temsirolimus. Part 1 and Part 2 will be conducted at the same time. Subjects can only participate in either Part 1 or Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide plus Quinidine | Experimental |
| |
| Lenalidomide plusTemsirolimus and Diphenhydramine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | 25 mg Lenalidomide capsule will be administered orally once in the first period, and once with Quinidine in the second period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lenalidomide PK-AUC (0-24) | Area under the plasma concentration-time curve from time zero to 24 hours post dose | Up to 21 days |
| Lenalidomide PK-(Cmax) | Maximum observed plasma concentration | Up to 21 days (including washout phase) |
| Lenalidomide PK-(Tmax) | Time to maximum observed plasma concentration | Up to 21 days |
| Lenalidomide PK-AUC(0-t) | Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point | Up to 21 days |
| Lenalidomide PK-AUC(0-∞) | Area under the plasma concentration-time curve from time zero extrapolated to infinity | Up to 21 days |
| Lenalidomide PK-(T1/2) | Estimate of the terminal elimination half-life in plasma | Up to 21 days |
| Temsirolimus and Sirolimus PK-AUC (0-24) | Area under the plasma concentration-time curve from time zero to 24 hours post dose | Up to 38 days |
| Temsirolimus and Sirolimus PK-(Cmax) | Maximum observed plasma concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Safety monitoring will be done by regular adverse event assessment, concomitant medication, clinical laboratory tests, physical exams, ECGs, and vital signs. | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward O'Mara, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Dallas | Dallas | Texas | 75247 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D011802 | Quinidine |
| C401859 | temsirolimus |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Quinidine | Drug | 300 mg of Quinidine will be administered orally every 12 hours for 1 day followed by 600 mg of Quinidine administered orally every 12 hours for the next 4 consecutive days |
|
| Temsirolimus | Drug | 25 mg/mL injection of Temsirolimus will be given directly into the vein over 30 minutes once in the second period and once with Lenalidomide in the third period. |
|
| Diphenhydramine | Drug | Just before Temsirolimus is given, 25 mg of Diphenhydramine (Benadryl) will be given directly into the vein to decrease chances of an allergic reaction to Temsirolimus. |
|
|
| Up to 38 days |
| Temsirolimus and Sirolimus PK-(Tmax) | Time to maximum observed plasma concentration | Up to 38 days |
| Temsirolimus and Sirolimus PK-(AUC 0-t) | Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point | Up to 38 days |
| 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 |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |