- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331941
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
November 1, 2017 updated by: Amgen
An Open-label Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects With Normal and Impaired Renal Function
This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of AMG 386 intravenously.
The primary objective is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various degrees of renal function.
Once the AMG 386 PK characterization is complete in the first 5 weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30332
- Research Site
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Illinois
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Chicago, Illinois, United States, 60637
- Research Site
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Research Site
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Ohio
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Cleveland, Ohio, United States, 44106
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women ≥ 18 years of age
- 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:
- Subjects with gastric cancer or any malignancy with purely squamous cell histology
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Cancer subjects with normal renal function.
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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.
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
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Experimental: Group 3
Cancer subjects with moderate renal impairment.
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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.
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
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Experimental: Group 4
Cancer subjects with severe renal impairment.
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15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
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Experimental: Group 2
Cancer subjects with mild renal impairment.
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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.
15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum concentration-time curve (AUC)
Time Frame: Week 1-5.
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Week 1-5.
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Maximum observed concentration (Cmax)
Time Frame: Week 1-5.
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Week 1-5.
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Time to maximum concentration (tmax)
Time Frame: Week 1-5.
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Week 1-5.
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Minimum observed concentration (Cmin)
Time Frame: Week 1-5.
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Week 1-5.
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Clearance (CL) of AMG 386 calculated as dose divided by AUC on week 5.
Time Frame: Week 1-5
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Week 1-5
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events as a measure of safety
Time Frame: Weekly at each visit AMG 386 is administered, on day 30, 31 and 32 when only PK assessments are scheduled up to and including the last study visit 30 days after the last AMG 386 administration.
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Weekly at each visit AMG 386 is administered, on day 30, 31 and 32 when only PK assessments are scheduled up to and including the last study visit 30 days after the last AMG 386 administration.
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Changes in vital signs as a measure of safety
Time Frame: Weekly at each visit AMG 386 is administered up to and including the last study visit 30 days after the last AMG 386 administration.
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Weekly at each visit AMG 386 is administered up to and including the last study visit 30 days after the last AMG 386 administration.
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Changes in clinical laboratory tests as a measure of safety
Time Frame: Weekly from week 1-9 then every 4 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.
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Weekly from week 1-9 then every 4 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.
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Anti-AMG 386 antibody formation
Time Frame: Week 1, week 5, week 9 and every 16 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.
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Week 1, week 5, week 9 and every 16 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.
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Tumor objective response measured by CT or MRI (without Gadolinium contrast agents) and assessed by RECIST 1.1 criteria.
Time Frame: Week 5 and every 8 weeks thereafter until the subject's end of participation in the study.
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Week 5 and every 8 weeks thereafter until the subject's end of participation in the study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2011
Primary Completion (Actual)
February 26, 2013
Study Registration Dates
First Submitted
March 24, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
November 1, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Kidney Diseases
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Paclitaxel
- Trebananib
Other Study ID Numbers
- 20090277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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