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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448786
• Other study ID #: 20060443
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2007
• Last updated: January 20, 2011
• Start date: February 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change from baseline in gallbladder size (volume by ultrasound)		Anticipated 8 months of treatment with AMG 706	Yes
Primary	Average change from baseline in gallbladder function (ejection fraction)		Subject treatment with AMG 706 anticipated to be 8 months	Yes
Secondary	Average changes from baseline in gallbladder size (volume by CT scan)		Subject treatment with AMG 706 anticipated to be 8 months	Yes
Secondary	Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)		Subject treatment with AMG 706 anticipated to be 8 months	Yes
Secondary	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	Yes
Secondary	Objective response in subjects with measurable disease at baseline		Subject treatment with AMG 706 anticipated to be 8 months	No
Secondary	Pharmacokinetics of AMG 706 monotherapy		Subject treatment with AMG 706 anticipated to be 8 months	No
Secondary	Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related		Subject treatment with AMG 706 anticipated to be 8 months	Yes
Secondary	Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge		Subject treatment with AMG 706 anticipated to be 8 months	Yes

External Links

•   AmgenTrials clinical trials website