Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors
NCT ID: NCT00448786
Last Updated: 2011-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2007-02-28
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm C
Arm C - AMG 706 75 mg BID 5-days on and 2-days off
AMG 706
Arm C - 75 mg BID 5-days on, 2-days off
Arm B
Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
AMG 706
Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
Arm A
Arm A = AMG 706 125 mg PO daily continuously
AMG 706
AMG 706 125 mg daily continuously (Arm A)
Interventions
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AMG 706
Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
AMG 706
Arm C - 75 mg BID 5-days on, 2-days off
AMG 706
AMG 706 125 mg daily continuously (Arm A)
Eligibility Criteria
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Inclusion Criteria
* 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 randomization
* Men and women 18 years or older
Exclusion Criteria
* 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 (vandetanib)
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Rosen LS, Lipton L, Price TJ, Belman ND, Boccia RV, Hurwitz HI, Stephenson JJ Jr, Wirth LJ, McCoy S, Hei YJ, Hsu CP, Tebbutt NC. The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors. BMC Cancer. 2013 May 16;13:242. doi: 10.1186/1471-2407-13-242.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060443
Identifier Type: -
Identifier Source: org_study_id
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