An Open Label Treatment Extension Study of AMG706

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

• Women and men > 18 years old, with solid tumors, previously treated with AMG 706 on an Amgen protocol
• Subject has completed the planned duration of AMG 706 treatment on a separate Amgen protocol and has been evaluated as having stable disease or better (as defined in the previous protocol) or is no longer eligible to continue AMG 706 treatment on a separate Amgen protocol for reasons other than AMG 706 intolerance, but is receiving clinical benefit from AMG 706 in the judgment of the investigator
• Subject has received AMG 706 treatment for at least 8 weeks or until the first protocol-specified tumor evaluation, whichever is longer
• Subject has been treated with AMG 706 in the previous study within the last 14 days (if > 14 days since date of last AMG 706 treatment, the subject will require repeat hematology and chemistry laboratory testing to confirm meet the laboratory criteria)
• Before any study-specific procedure, the appropriate written informed consent must be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease Related
• Discontinued from an AMG 706 study due to an adverse event considered by the investigator to be related to AMG 706 treatment, including intolerance to AMG 706, or for any other reason that a subject’s safety could be compromised with continued AMG 706 treatment
• Has been off AMG 706 treatment for > 42 days before study day 1
• Participating in any intervening investigational device or drug study(s) between the previous AMG 706 study and this AMG 706 study, or is receiving any investigational agent(s) other than AMG 706
• Current uncontrolled hypertension, defined as systolic BP > 145 mm Hg or diastolic BP > 90 mm Hg
• Requires additional systemic anticancer therapy for the primary tumor

Laboratory
The following laboratory exclusion criteria are applicable for repeat hematology and chemistry laboratory testing for subjects whose last date of AMG 706 treatment on a previous study has been > 14 days: • absolute neutrophil count (ANC) < 1.5 x 109 /L • platelet count < 100 x 109 /L • hemoglobin < 9 g/dL • serum creatinine > 2.0 mg/dL (> 177 µmol/L) or calculated clearance < 40 mL/min • aspartate aminotransferase (AST) > 2.5 x upper limits of normal (ULN), or AST > 5.0 x ULN if secondary to liver metastasis • total bilirubin > 2 x ULN 4.2.3

Medications
• Coumarin-type anticoagulants (including warfarin) > 2 mg/day must not be administered within 7 days before study day 1
• Currently or previously treated with rifampin or phenobarbital (within 14 days of study day 1) or ketoconazole, itraconazole, erythromycin, clarithromycin, nefazodone, cyclosporine, tacrolimus, and any HIV protease inhibitor (within 7 days of study day 1)
• Concurrent therapy with St. John’s Wort.

General
• Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breastfeeding
• Subject is not using adequate contraceptive precautions
• Subject has known sensitivity to any of the products to be administered during dosing
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
• Subject has any medical condition that, in the investigator’s opinion, makes the subject unsuitable for study participation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide ongoing treatment with AMG 706 monotherapy for those subjects who have completed the planned duration of treatment with AMG 706 on a separate Amgen protocol and demonstrate continuing clinical benefit from AMG 706 therapy.<br><br>To provide ongoing treatment with AMG 706 for subjects who were not eligible to remain on a separate Amgen protocol for reasons other than AMG 706 intolerance, but continue to experience clinical benefit.;Secondary Objective: To evaluate the safety profile of AMG 706, including adverse events and serious adverse events, for all subjects on continued AMG 706 treatment.;Primary end point(s): Safety (serious adverse events, adverse events, blood pressure, and laboratory parameters), tumor response, and progression-free survival

Secondary Outcome Measures

Name	Time	Method

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