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An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Histologically confirmed advanced metastatic solid tumor

- Ineligible to receive or progressed on standard of care therapies

- Measurable or non-measurable disease per modified RECIST

- Gallbladder must be in situ on screening ultrasound

- ECOG Performance Status of 0 to 2

- Life expectancy of 6 months or more as determined by the investigator

- Adequate organ and hematologic function as evidenced by laboratory studies prior to

- Men and women 18 years or older

Exclusion Criteria:

- Uncontrolled CNS metastases

- Known history of prior cholecystitis, prior biliary procedure or prior or ongoing
biliary disease

- Radiation therapy within 14 days prior to randomization

- Peripheral neuropathy > Grade 1 per CTC AE v.3

- Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248
(sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474

- Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from
the last dose of bevacizumab to the date of randomization

- Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin
and warfarin for prophylaxis against central venous catheter thrombosis is allowed

- Less than 30 days have elapsed since participation in an investigational drug/device
study or currently receiving investigational treatments

- History of arterial or venous thrombosis within 1 year prior to randomization

- History of bleeding diathesis or bleeding within 14 days of randomization

- MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or
unstable angina within one year prior to randomization

- Uncontrolled HTN defined by a resting BP of >150/90 mmHg

- Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization;
minor surgical procedure, placement of access device or fine needle aspiration within
7 days of randomization; planned elective surgery while on study

- Non-healing or open wound, ulcer or fracture

- Known ongoing or active infection

- Known (+) for HIV, Hep C or Hep B surface antigen

- Known chronic hepatitis

- Known history of allergy or hypersensitivity to AMG 706 or any of its components

- Pregnant, ie, (+) b-HCG; breastfeeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Average change from baseline in gallbladder size (volume by ultrasound)

Outcome Time Frame:

Anticipated 8 months of treatment with AMG 706

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Human Research Ethics Committee

Study ID:




Start Date:

February 2007

Completion Date:

March 2009

Related Keywords:

  • Solid Tumors
  • gallbladder
  • AMG 706
  • solid tumors
  • Phase 1b
  • Amgen
  • Neoplasms