Subjects With Solid Tumors Previously Treated on a Seperate Amgen Protocol With AMG 706
Conditions
Interventions
Product Name: AMG706
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: AMG 706-21
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Current Sponsor co
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 or has potential to receive clinical benefit from AMG 706 in the judgment of the investigator Subject must meet one of the following criteria: • Subject has received AMG 706 treatment for at least 8 weeks or until the first protocol-specified tumor evaluation, whichever is longer or • Subject has received at least one dose of AMG 706 but did not receive AMG 706 for > 8 weeks or undergo a tumor evaluation due to the construct of the parent protocol. These subjects will be evaluated for eligibility on a case by case basis by the sponsor • 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
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 • Uncontrolled hypertension (resting blood pressure > 150/ 90 mm Hg). Anti- hypertensive medications are allowed if the subject is stable on their current dose at time of study day 1. • 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 dose of AMG 706 treatment on the previous study has been > 14 days from the first dose of AMG 706 on this extension study: • absolute neutrophil count (ANC) 2.0 mg/dL (> 177 µmol/L) or calculated clearance 2.5 x upper limit of normal (ULN) (if liver metastases are present = 5 x ULN) • Alanine aminotransferase (ALT) > 2.5 x ULN ( if liver metastases are present =5 x ULN) • Alkaline phosphatase > 2.0 x ULN ( if liver or bone metastases are present = 5 x ULN) • Total bilirubin > 2.0 x ULN (except for subjects with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader° UGT1A1 Molecular Assay prior to randomization. Subjects enrolled with Gilbert syndrome must have a total bilirubin < 3 x ULN) Medications Medications that are metabolized by CYP3A4, 2D6 and 2C9 and that have a narrow therapeutic window should be used with caution when given concomitantly with AMG 706, or alternative therapeutic agents with less drug interaction potential should be considered. General • Subject of child-bearing potential is evidently pregnant (eg, positive beta-human chorionic gonadotropin test) or is breastfeeding • Is not using adequate contraceptive precautions • Subject has known sensitivity to any of the products to be administered during dosing Known hypertension to study medication (AMG706) • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 or have the potential to experience clinical benefit as assessed by the Principal Investiagtor.;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 | — |
Countries
Austria, Belgium, Denmark, Germany, Hungary, Italy, Sweden, United Kingdom
Outcome results
None listed