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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00392444 |
Purpose
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: sunitinib malate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma |
| Enrollment: | 39 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sunitinib
50mg orally daily for 4 out of 6 weeks.
|
Drug: sunitinib malate
50mg orally daily for 4 our of 6 weeks.
|
OBJECTIVES:
OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until progression and treatment related toxicities resolve.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
Meets 1 of the following criteria for prior cytotoxic chemotherapy treatment:
PATIENT CHARACTERISTICS:
Patients with the following histories allowed provided they are asymptomatic with respect to cardiac function and LVEF is normal by MUGA at baseline:
No cardiac disease within the past 12 months, including any of the following:
No bowel obstruction or any condition that would impair the ability to swallow and retain sunitinib malate, including any of the following:
No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No prior treatment with any other antiangiogenic agents or multitargeted tyrosine kinase inhibitors, including any of the following:
No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
No concurrent agents with proarrhythmic potential, including any of the following:
Contacts and Locations| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| BCCA - Cancer Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BCCA - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| BCCA - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Ottawa Health Research Institute - General Division | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada | |
| University Institute of Cardiology and | |
| Quebec, Canada, G1V 4G5 | |
| Study Chair: | Scott A. Laurie, MD, FRCPC | Ottawa Regional Cancer Centre |
More Information
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00392444 History of Changes |
| Other Study ID Numbers: | I183, CAN-NCIC-IND183, CDR0000509318 |
| Study First Received: | October 25, 2006 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
advanced malignant mesothelioma recurrent malignant mesothelioma |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |