Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors
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
1 other identifier
interventional
49
0 countries
N/A
Brief Summary
The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2007
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 15, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJanuary 21, 2011
January 1, 2011
1.8 years
March 15, 2007
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average change from baseline in gallbladder size (volume by ultrasound)
Anticipated 8 months of treatment with AMG 706
Average change from baseline in gallbladder function (ejection fraction)
Subject treatment with AMG 706 anticipated to be 8 months
Secondary Outcomes (7)
Average changes from baseline in gallbladder size (volume by CT scan)
Subject treatment with AMG 706 anticipated to be 8 months
Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)
Subject treatment with AMG 706 anticipated to be 8 months
Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement
Subject treatment with AMG 706 anticipated to be 8 months
Objective response in subjects with measurable disease at baseline
Subject treatment with AMG 706 anticipated to be 8 months
Pharmacokinetics of AMG 706 monotherapy
Subject treatment with AMG 706 anticipated to be 8 months
- +2 more secondary outcomes
Study Arms (3)
Arm C
OTHERArm C - AMG 706 75 mg BID 5-days on and 2-days off
Arm B
OTHERArm B - AMG 706 75 mg BID 2-weeks on and 1-week off
Arm A
OTHERArm A = AMG 706 125 mg PO daily continuously
Interventions
Eligibility Criteria
You may qualify if:
- 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 randomization
- Men and women 18 years or older
You may not qualify if:
- 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 (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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
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.
PMID: 23679351DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2007
First Posted
March 19, 2007
Study Start
February 1, 2007
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
January 21, 2011
Record last verified: 2011-01