Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer (NCT01935934) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
United States102 participantsStarted 2013-05-08
Plain-language summary
This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed metastatic endometrial cancer; eligible histologies for the experimental cohort are: endometrioid or serous; eligible histologies for the exploratory cohort are: carcinosarcoma, clear cell, mixed, adenosquamous and any other rare sub-type of endometrial cancer
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam and \>= 15 mm in short axis for nodal lesions; patients must have radiographic evidence of disease progression following the most recent line of treatment
* Prior therapy: Eligible subjects must have had 1 line of systemic cytotoxic treatment; this may be adjuvant therapy with documented progression within 12 months of completion, or 1 line of cytotoxic therapy for metastatic disease; NOTE: eligible patients are allowed up to 2 lines of systemic cytotoxic treatment, of which only 1 line is allowed for metastatic disease; the acceptance of progression within 12 months of adjuvant is part inclusion to not require patient to re-challenge with chemotherapy (chemo) if they progressed soon after adjuvant therapy; prior hormonal therapy for metastatic/recurrent disease is also allowed; prior targeted therapy not directe…
What they're measuring
1
Response Rate
Timeframe: 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
2
Progression-free Survival
Timeframe: Time from start of treatment to time of progression or death, assessed at 12 weeks