AMG 386 Drug-Drug Interaction Study With Paclitaxel
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01992341|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: AMG 386 Drug: Paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Pharmacokinetic Drug-Drug Interaction (DDI) Study of AMG 386 in Combination With Paclitaxel in Adult Subjects With Advanced Solid Tumors|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2014|
|Experimental: AMG 386 15mg/kg and paclitaxel 80mg/m2||
Drug: AMG 386
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.
Other Name: Taxol
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.
- Paclitaxel PK parameters [ Time Frame: 9 weeks ]Paclitaxel PK parameters with and without the co-administration of AMG 386.
- AMG 386 PK parameters [ Time Frame: 9 weeks ]AMG 386 PK steady state PK parameters with and without paclitaxel co-administration
- Safety [ Time Frame: Average of 6 months ]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
- Safety [ Time Frame: Average of 6 months ]Incidence of anti-AMG 386 antibody formation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992341
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Utah|
|University of Utah Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|