A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours

Phase 2

Active, not recruiting

• Conditions: Advanced Rare Tumours
• Interventions: Drug: Sunitinib; Drug: Temsirolimus

• Registration Number: NCT01396408
• Lead Sponsor: Canadian Cancer Trials Group

Brief Summary

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.

Detailed Description

The purpose of this study is to find out what effects the study drugs - sunitinib or temsirolimus - will have on this type of cancer. The study will begin by finding out if sunitinib can shrink the cancer. If sunitinib does not work, temsirolimus will be tested next.

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2012-02-09
• Primary Completion: 2015-07-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunitinib	Sunitinib	-
Temsirolimus	Temsirolimus	-

Primary Outcome Measures

Name	Time	Method
Objective Response	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

Secondary Outcome Measures

Name	Time	Method
Safety Monitoring	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.
Efficacy Outcomes	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	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.

Trial Locations

Locations (17)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

BCCA - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Izaak Walton Killam (IWK) Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

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