E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic colorectal cancer |
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E.1.1.1 | Medical condition in easily understood language |
Cancer in the colon or rectum that has spread to other organs in the body |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 evaluate the feasibility of continous treatment with bevacizumab beyond disease progression in an elderly community based patient population by assessment of overall survival |
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E.2.2 | Secondary objectives of the trial |
To assess safety, treatment duration, progression free survival, patient reported outcomes, overall response and tumor biomarker expression in elderly patients treated with bevacizumab beyond disease progression. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Untreated metastatic colorectal carcinoma
o Age ≥ 70 years
o Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria
o Eastern Cooperative Oncology Group (ECOG) performance status ≤2
o Life expectancy more than 3 months but not considered optimal candidate for treatment with combination chemotherapy with oxaliplatin or irinotecan
o Adequate haematological, renal and liver function as measured by:
haemoglobin >90 g/L
absolute neutrophil count ≥ 1,5 x 109/L
platelets ≥ 100 x 109/L
bilirubin ≤1.5 × ULN
ALAT≤ 2.5 × ULN (<5 × ULN if liver metastases)
creatinine ≤1.5 × ULN
PK ≤ 1.5
APTT <1.5 ULN
Urine dipstick of proteinuria <2+
o Tumor tissue available for biomarker analysis.
o Signed written informed consent to the clinical study and translational research according to ICH/GCP and the local regulations will be obtained prior to any study specific screening procedures
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E.4 | Principal exclusion criteria |
o Adjuvant therapy within 6 months
o Clinically significant (i.e. active) cardiovascular disease, e.g:
cerebrovascular accidents ≤ 6 months prior to study enrolment
myocardial infarction ≤ 6 months prior to study enrolment
unstable angina
congestive heart failure (NYHA Grade II or greater)
serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.
o Surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study.
o Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival from time of enrolment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Survival follow-up throughout the study and every three months after teminated study participation |
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E.5.2 | Secondary end point(s) |
Safety
Total treatment duration
Treatment duration from first progression
Progression free survival
Patient reported outcomes
Overall response rate
Tumor biomarker expression |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety is assessed throughout the study at every patient visit. Any serious adverse events or adverse events of special interest is follwed until return to baseline, stabilization or death.
Total treatment duration and treatment duration from first progression is followed until last treatment dose is received
Progression free survival is assessedd every 9-12 weeks and every three monts after study termination until disease progression or death.
Patient reported outcomes are assessed before every treatment upto 30 days after last treatment
Overall response rate is assessedd every 9-12 weeks
Tumor biomarker expression is assessed in tumour material obtained during the screening phase |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |