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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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29 June 2015 |
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Main ID: |
NCT02402777 |
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Date of registration:
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21/03/2015 |
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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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A Study Of Effectiveness Of Axitinib (CT), In Comparison With Axitinib - Pfizer (INLYTA) Confirmed Objective Response (ORR) In Patients With Solid Tumors
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Scientific title:
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A Study Of Effectiveness Of Axitinib (CT), In Comparison With Axitinib - Pfizer (INLYTA) Confirmed Objective Response (ORR) In Patients With Solid Tumors |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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280 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02402777 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belarus
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Germany
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Poland
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Romania
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Russian Federation
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Ukraine
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Contacts
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Name:
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Viktor Lanevskij |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cancer Center |
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Name:
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Viktor Lanevskij, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with cytologically or histologically confirmed solid tumor(s) and with at
least one measurable disease site
- Patients with adequate bone marrow, liver and kidney function
- Patients with life expectancy of at least 12 weeks
Exclusion Criteria:
- Patients who have received chemotherapy, immunotherapy, radiotherapy or any
investigational agent within 4 weeks of study entry
- Patients with have had a major surgical procedure within 4 weeks of study entry
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Solid Tumors
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Intervention(s)
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Drug: Axitinib (CT)
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Drug: Axitinib (Pfizer)
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Primary Outcome(s)
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The effectiveness of Axitinib (CT), in comparison with Axitinib - Pfizer (INLYTA) confirmed objective response (ORR) on 5-12-19 - weeks treatment of patients with advanced solid tumors (Glioblastoma also)
[Time Frame: up to 54 weeks]
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Secondary Outcome(s)
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Number of Participants With Progression Free Survival (PFS)
[Time Frame: up to 54 weeks]
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Secondary ID(s)
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XTPTC-308-54
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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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