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Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00448786
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : January 21, 2011
Sponsor:
Information provided by:
Amgen

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: AMG 706 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Arm C
Arm C - AMG 706 75 mg BID 5-days on and 2-days off
Drug: 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
Drug: 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
Drug: AMG 706
AMG 706 125 mg daily continuously (Arm A)




Primary Outcome Measures :
  1. Average change from baseline in gallbladder size (volume by ultrasound) [ Time Frame: Anticipated 8 months of treatment with AMG 706 ]
  2. Average change from baseline in gallbladder function (ejection fraction) [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]

Secondary Outcome Measures :
  1. Average changes from baseline in gallbladder size (volume by CT scan) [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  2. Maximum change from baseline in gallbladder size (volume) and function (ejection fraction) [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  3. Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  4. Objective response in subjects with measurable disease at baseline [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  5. Pharmacokinetics of AMG 706 monotherapy [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  6. Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]
  7. Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge [ Time Frame: Subject treatment with AMG 706 anticipated to be 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 randomization
  • 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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448786


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00448786    
Other Study ID Numbers: 20060443
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011
Keywords provided by Amgen:
gallbladder
AMG 706
solid tumors
Phase 1b
Amgen
Additional relevant MeSH terms:
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Neoplasms
Niacinamide
Motesanib diphosphate
Imetelstat
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs