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The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of paclitaxel
Eligible subjects enrolled in the study will begin receiving paclitaxel on a three weeks on / one week off schedule at study day 1 and weekly AMG 386 beginning at study day 8. The pharmacokinetic portion of the study occurs during the first two study cycles with intensive PK collections on study weeks 1, 6 and 8. Once the pharmacokinetic assessment period is completed, continued combination therapy with AMG 386 and paclitaxel or single-agent AMG 386 will be administered at the investigator's discretion until progression, unacceptable toxicity develops, or study withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 386 15mg/kg and paclitaxel 80mg/m2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 386 | Drug | Weekly 15 mg/kg of AMG 386 in combination with three weeks on/ one week off 80mg/m2 of paclitaxel. Continued therapy with AMG 386 with or without paclitaxel until progression, unacceptable toxicity develops, or study withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Paclitaxel PK parameters | Paclitaxel PK parameters with and without the co-administration of AMG 386. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AMG 386 PK parameters | AMG 386 PK steady state PK parameters with and without paclitaxel co-administration | 9 weeks |
| Safety | Subject incidence of treatment-emergent adverse events: Assessments include physical examinations, vitals, clinical laboratories, and electrocardiograms (ECG) • Results of safety laboratory tests, vital sign measurements, and ECG measurments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| University of Utah Huntsman Cancer Institute |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C551398 | trebananib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Paclitaxel | Drug | Three weeks on/ one week off 80mg/m2 of paclitaxel in combination with weekly 15 mg/kg of AMG 386 . Continued therapy with AMG 386 until progression, unacceptable toxicity develops, or study withdrawal. A cycle consists of 3 weeks on / 1 week off of paclitaxel. |
|
| Average of 6 months |
| Safety | Incidence of anti-AMG 386 antibody formation | Average of 6 months |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |