Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT00478426|
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinoma Endometrial Endometrioid Adenocarcinoma Endometrial Serous Adenocarcinoma Recurrent Uterine Corpus Carcinoma Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Uterine Corpus Cancer AJCC v7 Uterine Carcinosarcoma Uterine Corpus Carcinosarcoma||Drug: Sunitinib Malate||Phase 2|
I. To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib (sunitinib malate).
II. To assess the frequency of prolonged stable disease (as defined by percentage [%] of patients alive and free from progressive disease at 6 months) in patients with recurrent or metastatic endometrial cancer treated with sunitinib.
I. To assess time-to- progression, median overall survival, and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib.
II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer.
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3 months until relapse.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma|
|Actual Study Start Date :||April 30, 2007|
|Actual Primary Completion Date :||February 12, 2019|
|Actual Study Completion Date :||February 12, 2019|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Sunitinib Malate
- Objective Response Rate [ Time Frame: Up to 7 years ]Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), disappearance of all target lesions.
- Number of Participants With Prolonged Stable Disease [ Time Frame: Up to 7 years ]Described as the best response of stable disease that is maintained for atleast 6 months
- Overall Survival [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method.
- Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0 [ Time Frame: Up to 7 years ]Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE.
- Time to Progression [ Time Frame: Up to 7 years ]The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method
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): NCT00478426
|Principal Investigator:||Amit M Oza||University Health Network-Princess Margaret Hospital|