E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A phase II, open label, non-randomized, multi-center, pilot, efficacy study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a tool to monitor response to an anti-angiogenic drug. |
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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 |
The primary objective for this study is to explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed. |
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E.2.2 | Secondary objectives of the trial |
• To continue safety evaluation by collection of safety data from all patients • To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient is >18 years and male or female of any race / ethnicity • Patient or patient’s legally acceptable representative provides written informed consent and willing to comply with protocol requirements • Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for non-squamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer) • Patient will be scheduled to have a clinical [F-18] FDG-PET/CT or diagnostic CT pretreatment, and after the fourth but before the fifth Avastin® treatment |
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E.4 | Principal exclusion criteria |
• Patient is not capable of complying with study procedures • Female patient is pregnant or nursing • Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: o AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limits of normal o Serum creatinine = 2x institutional upper limits of normal o BUN within 2x institutional upper limits of normal • Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: o Platelet counts of < 75 x 103/µL • Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies • Patient has been involved in an investigative, radioactive research procedure or within 7 days and during the study participation period • Patient will participate in experimental therapy procedures while participating in this clinical trial • Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations |
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E.5 End points |
E.5.1 | Primary end point(s) |
• To use [F-18]RGD-K5 PET/CT imaging acquired at several times points to evaluate tumor response to Avastin® at earlier time points (changes from baseline to after the second but before the third Avastin® treatment, and from baseline to after the fourth but before the fifth Avastin® treatment) • To compare lesion changes in a paired image assessment from the diagnostic CT or [F-18]FDG PET/CT with the lesion changes in a paired image assessment from [F-18]RGD-K5 PET/CT obtained from pretreatment and after the fourth Avastin® treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |