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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01830647 |
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Date of registration:
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10/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
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Scientific title:
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Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01830647 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Montenegro
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with
evidence of metastases
- At least one measurable metastatic lesion (as per RECIST criteria)
- Life expectancy of > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
Exclusion Criteria:
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
- Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose
for gastrointestinal ulceration
- Participation in an investigational trial in the previous 3 months
- Pregnant or lactating women
- History of thrombotic or haemorrhagic disorders
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension
- Known hypersensitivity to Avastin and any of its excipients, or any of the
chemotherapies
- Evidence of any disease or disorder that contraindicates the use of an
investigational drug or puts the patient at high risk for treatment-related
complications
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Primary Outcome(s)
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Safety: Incidence of adverse events
[Time Frame: approximately 3.5 years]
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Secondary Outcome(s)
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Efficacy: Time to disease progression
[Time Frame: approximately 3.5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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