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

Amgen

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: AMG 706

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448786

20060443

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

Arm C

Other group

Description:

Arm C - AMG 706 75 mg BID 5-days on and 2-days off

Treatment:

Drug: AMG 706

Drug: AMG 706

Drug: AMG 706

Arm B

Other group

Description:

Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off

Treatment:

Drug: AMG 706

Drug: AMG 706

Drug: AMG 706

Arm A

Other group

Description:

Arm A = AMG 706 125 mg PO daily continuously

Treatment:

Drug: AMG 706

Drug: AMG 706

Drug: AMG 706