Phase 2
N=57
Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
Renal Cell Cancer · Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00465179 ↗Enrolled (actual)
57
Serious AEs
100.0%
Results posted
May 2016
Primary outcome: Primary: Number of Participants With Response to Treatment — 0; 3; 29; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib Malate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response to Treatment |
0; 3; 29; 23 | — |
| PRIMARY Median Progression-Free Survival (PFS) |
2.7 | — |
| SECONDARY Median Overall Survival |
16.8 | — |
Summary
The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with conventional-type renal cell carcinoma who have >/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in fine-needle aspiration (FNA) or core biopsy of any metastatic site are eligible.
- Patients must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/= 1,500/microliter (microL), platelets >/= 100,000/microL, total bilirubin 150/90 on therapy), corrected QT interval (QTc) interval > 500msec or other significant ECG abnormalities or uncontrolled DM.
- Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.
- Patients unwilling to participate or unable to comply with the protocol for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT00465179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.