A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours
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|ClinicalTrials.gov Identifier: NCT01396408|
Recruitment Status : Active, not recruiting
First Posted : July 18, 2011
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Rare Tumours||Drug: Sunitinib Drug: Temsirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours|
|Actual Study Start Date :||July 14, 2011|
|Actual Primary Completion Date :||July 6, 2015|
|Estimated Study Completion Date :||December 31, 2021|
|Active Comparator: Sunitinib||
50 mg PO daily for 28 days, q 6 weeks (1 cycle=6 weeks or 42 days)
|Active Comparator: Temsirolimus||
25 mg IV weekly (Days 1, 8, 15, 22, 29, 36), q 6 weeks (1 cycle=6 weeks or 42 days)
- Objective Response [ Time Frame: Every 4 weeks ]Objective response as assessed by RECIST version 1.1 criteria as a 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks. Early progression is defined as progressive disease at or prior to the first assessment. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed
- Efficacy Outcomes [ Time Frame: 48 months ]
- Response duration: median and range
- Time to progression: median, 95% confidence interval
- Progression free survival: median, 95% confidence interval
- Overall survival: median, 95% confidence interval
- Comparison of the time to first and second progression for patients who receive sunitinib and temsirolimus in sequence.
- Translational Research [ Time Frame: 48 months ]Primary tumour tissue specimens and baseline blood samples, will be obtained from all subjects prior to first dose for genetic analysis and other evaluation. In addition, optional for responding patients will be a fresh tumour biopsy at time of progression and also optional for patients entered in the second stage of accrual for any disease cohort will be fresh tumour biopsy at baseline.
- Safety Monitoring [ Time Frame: Daily up to an expected average of 4 weeks after treatment ]Adverse events will be monitored on an ongoing basis by the central office and their frequencies reported annually at investigators' meetings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396408
|Study Chair:||Hal Hirte||Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada|