Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT01935934|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2013
Results First Posted : July 14, 2020
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Metastatic Endometrioid Adenocarcinoma Recurrent Uterine Corpus Carcinoma Stage IV Uterine Corpus Cancer AJCC v7 Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Uterine Corpus Cancer AJCC v7 Uterine Corpus Carcinosarcoma||Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS).
I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor [c-met] amplification & mutation status) and overall survival.
Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer|
|Actual Study Start Date :||April 29, 2013|
|Actual Primary Completion Date :||September 12, 2019|
Experimental: Treatment (cabozantinib s-malate)
Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Response Rate [ Time Frame: At 12 weeks, then every 8 weeks during treatment; up to 12 weeks post-treatment if discontinued due to toxicities, a maximum of 16 weeks ]Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression-free Survival [ Time Frame: Time from start of treatment to time of progression or death, assessed at 12 weeks ]Defined as the percentage of patients progression free 12 weeks from starting treatment.
- Number of Participants With Archival Specimens That Had C-met Amplification or Mutation [ Time Frame: Baseline ]
Will correlate with clinical response.
83 tumors were profiled on the NGS TruSeq amplicon panel and 1 on Sequenom. Fields with at least 50 tumor cells were captured to analyze 100 non-overlapping tumor cell nuclei to calculate a ratio of MET to CEP7 signal; MET ampliction was defined as MET/CEP7 ratio >=2.
- Pharmacodynamic Responses in Levels of Soluble, Circulating Angiogenic Factors [ Time Frame: Baseline and day 1 of course 2 ]Will correlate with clinical response.
- Overall Survival [ Time Frame: Time from start of treatment to time of death, assessed up to 4 years ]Will correlate with clinical response.
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): NCT01935934
|Principal Investigator:||Neesha Dhani||University Health Network-Princess Margaret Hospital|