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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Phase 2 trial testing sunitinib malate in Clear Cell Renal Cell Carcinoma in 37 participants. Completed in 1 February 2017.
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 18 August 2010 |
| Primary completion | 20 June 2013 |
| Estimated completion | 1 February 2017 |
| Sites | 1 location across United States |
Case Comprehensive Cancer Center — full company profile →
18 and older, any sex, with Clear Cell Renal Cell Carcinoma or Stage IV Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 20 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I |
|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Gastrointestinal disorder - other | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Edema Trunk | General disorders | — |
| Fever | General disorders | — |
| Abdominal infection | Infections and infestations | — |
| Infection and infestation - other | Infections and infestations | — |
| Lung infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Weight Gain | Investigations | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Intracranial Hemorrhage | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Proteinuria | Renal and urinary disorders | — |
| Renal and urinary disorders - other | Renal and urinary disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders - other | Respiratory, thoracic and mediastinal disorders | — |
| Palmar-Plantar Erythrodysesthesia Syndrome | Skin and subcutaneous tissue disorders | — |
| Thromboembolic Event | Vascular disorders | — |
| Reaction | System | Arm I |
|---|---|---|
| Fatigue | General disorders | — |
| Mucositis Oral | Gastrointestinal disorders | — |
| Platelet Count Decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| White Blood Cell Decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Palmar-plantar Erythrodysesthesia Syndrome | Skin and subcutaneous tissue disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Neutrophil Count Decreased | Investigations | — |
| Creatinine Increased | Investigations | — |
| Pain | General disorders | — |
| Weight Loss | Investigations | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Aspartate Aminotranferase Increased | Investigations | — |
| Edema limbs | General disorders | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Alanine Aminotransferase Increased | Investigations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Headache | Nervous system disorders | — |
| Rash Acneiform | Skin and subcutaneous tissue disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Hyperclycemia | Metabolism and nutrition disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Purpura | Skin and subcutaneous tissue disorders | — |
| Hemorrhoids | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Abdominal Pain, Upper respiratory infection, Atrial Fibrillation, Diarrhea, Gastrointestinal disorder - other, Chills, Edema Trunk, Fever.
Data from ClinicalTrials.gov NCT01158222 adverse events section.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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