E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects With Solid Tumors Previously Treated on a Seperate Amgen Protocol With AMG 706 |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety profile of AMG 706, including adverse events and serious adverse events, for all subjects on continued AMG 706 treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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) < 1.0 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 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety (serious adverse events, adverse events, blood pressure, and laboratory parameters), tumor response, and progression-free survival |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date that the subject is last evaluated for the study after ending AMG 706 treatment. In most cases this will be the date of the safety follow-up visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |