To Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 386 When Used in Combination With AMG 706, Bevacizumab, Sorafenib, or Sunitinib.

Sponsor
Amgen
Study ID
NCT00861419
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sorafenib — DRUG
    Sorafenib 400 mg PO (BID)
  • AMG 706 — DRUG
    AMG 706 125 mg PO (QD)
  • AMG 706 — DRUG
    AMG 706 75 mg PO (QD)
  • AMG 386 — DRUG
    AMG 386 10 mg/kg IV (QW)
  • Sunitinib — DRUG
    Sunitinib 50 mg PO (QD)
  • Bevacizumab — DRUG
    Bevacizumab 15mg/kg IV Q3W
  • AMG 386 — DRUG
    AMG 386 3 mg/kg IV (QW)

Study Details

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at least one dose level from each combination will be safe and well tolerated. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Key Dates

First listed
Mar 13, 2009
Start date
Dec 31, 2005
Status verified
Feb 2017

Study Design

Enrollment
88 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: D
    3 mg/kg AMG 386 IV (QW) / 125 mg AMG 706 PO (QD)
  • Experimental: A
    3 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
  • Experimental: B
    3 mg/kg AMG 386 IV (QW) / 75 mg AMG 706 PO (QD)
  • Experimental: E
    3 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)
  • Experimental: H
    10 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
  • Experimental: G
    3 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
  • Experimental: C
    10 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
  • Experimental: F
    10 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)

Primary Outcome Measure

Safety including adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study. Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.

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