A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
NCT ID: NCT01331941
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2011-09-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Cancer subjects with normal renal function.
AMG 386 + Paclitaxel
15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
AMG 386
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
Group 3
Cancer subjects with moderate renal impairment.
AMG 386 + Paclitaxel
15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
AMG 386
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
Group 4
Cancer subjects with severe renal impairment.
AMG 386
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
Group 2
Cancer subjects with mild renal impairment.
AMG 386 + Paclitaxel
15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
AMG 386
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
Interventions
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AMG 386 + Paclitaxel
15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
AMG 386
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
Eligibility Criteria
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Inclusion Criteria
* Must have a pathologically documented, and definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
* Evaluable OR measurable disease by RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Life expectancy of \> 3 months, in the opinion of and as documented by the investigator
* Subject or subject's legally acceptable representative has provided informed consent
Exclusion Criteria
* Known history of primary central nervous system (CNS) tumors or CNS metastases
* Myocardial infarction within 1 year before study day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association \> class II, uncontrolled hypertension \[diastolic \> 90 mmHg; systolic \> 150 mmHg in repeated measurements\])
* History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study day 1
* Active grade 2 or greater peripheral vascular disease or peripheral edema
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
* Non-healing wound, ulcer (including gastrointestinal) or fracture
* Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection
* Major surgery within 4 weeks before study day 1
* Absolute neutrophils count (ANC) \< 1.0 x 10\^9/L; or platelet count \< 100 x 10\^9/L; or hemoglobin \< 9 g/dL; or PTT / aPTT \> 1.5 x institutional upper limit of normal (ULN) ); or INR \> 1.5
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN (\> 5.0 x ULN if liver metastases present)
* Alkaline phosphatase \> 2.5 x ULN (\> 5.0 x ULN if attributable to liver or bone metastasis)
* Total bilirubin \> 1.5 x ULN
* Other investigational procedures during the study
* Previous anti-cancer therapy or investigational agent within 4 weeks prior to study day 1
* Anticoagulation therapy within 4 weeks of study day 1 and while on study (except low dose warfarin (≤ 2 mg/kg) for prophylaxis against central venous catheter thrombosis)
* Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or IUD (women).
* Women who are lactating/breastfeeding.
* Women with a positive pregnancy test.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Cleveland, Ohio, United States
Countries
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References
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Wu B, Lewis LD, Harvey RD, Rasmussen E, Gamelin E, Sun YN, Friberg G, Koyner JL, Dowlati A, Maitland ML. A Pharmacokinetic and Safety Study of Trebananib, an Fc-Fusion Peptibody, in Patients With Advanced Solid Tumors and Varying Degrees of Renal Dysfunction. Clin Pharmacol Ther. 2017 Aug;102(2):313-320. doi: 10.1002/cpt.617. Epub 2017 Jun 9.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090277
Identifier Type: -
Identifier Source: org_study_id