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An Open-label Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects With Normal and Impaired Renal Function

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors, Kidney Disease, Renal Impairment

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Trial Information

An Open-label Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects With Normal and Impaired Renal Function

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area under the serum concentration-time curve (AUC)

Outcome Time Frame:

Week 1-5.

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Tumors
  • Kidney Disease
  • Renal Impairment
  • AMG 386
  • Pharmacokinetic
  • Renal Impairment
  • Kidney Diseases
  • Renal Insufficiency



Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Hooksett, New Hampshire  
Research Site Akron, Ohio