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

NCT00861419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-02-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sorafenib

Sorafenib 400 mg PO (BID)

DRUG

AMG 706

AMG 706 125 mg PO (QD)

DRUG

AMG 706

AMG 706 75 mg PO (QD)

DRUG

AMG 386

AMG 386 10 mg/kg IV (QW)

DRUG

Sunitinib

Sunitinib 50 mg PO (QD)

DRUG

Bevacizumab

Bevacizumab 15mg/kg IV Q3W

DRUG

AMG 386

AMG 386 3 mg/kg IV (QW)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861419 on ClinicalTrials.gov