Clinical trial · Interventional
Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -
NCT00371553CI-TRIAL-00002440completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Cisplatin-Refractory Germ Cell Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SU011248 (Sunitinib) | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response Rate
Secondary outcomes (4)
- measure
- Rate and duration of stable disease
- measure
- Time to progression.
- measure
- Median and 1 yr survival
- measure
- Safety and tolerability of SU011248
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with histologically proven seminomatous or non-seminomatous germ cell cancer * patients with relapse within 8 weeks after at least 2 different cisplatin- based regimens or * patients with disease progression or relapse after salvage high-dose chemotherapy or patients with disease progression during cisplatin-based chemotherapy or patients with contraindications for other aggressive chemotherapy * measurable disease * Life expectancy of greater than 3 months * Karnofsky Performance status \> 60 * age \> 18 * adequate organ function * Resolution of acute toxic effects of prior radiotherapy, surgical procedure or chemotherapy to NCI CTCAE Version 3.0 \<= grade 1. * Left ventricular ejection fraction (LVEF) \>= lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan or echocardiography * Signed and dated informed consent document * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Acute infection * Uncontrolled intercurrent illness * Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non melanomatous skin cancers) are excluded. * Interval from last chemotherapy \< 3 weeks. * Simultaneous radiation of the only target lesion * NCI CTCAE grade 3 hemorrhage \< 4 weeks of starting the study treatment * Patients must not be on therapeutic anticoagulation. * Major surgery or radiation therapy within \< 4 weeks of starting the study treatment. * History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease * Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication. * Ongoing cardiac arrhythmias of NCI CTCAE grade \>= 2, atrial fibrillation of any grade, or prolongation of the QTc interval to \>500 msec on baseline EKG. * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy). * Current treatment on another clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.