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NCT00496756
Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Phase 2 trial testing Sorafenib in Kidney Cancer in 14 participants. Terminated before completion.
31 October 2009
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 1 March 2007 |
| Primary completion | 31 October 2009 |
| Estimated completion | 25 April 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sorafenib (SORAFENIB) — full drug profile →
Conditions studied
- Kidney Cancer — all drugs for Kidney Cancer →
Sponsor
University of Nebraska
Who can join
Adults 18 to 120, any sex, with Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events and serious adverse events will be collected and reported on the forms beginning with the first dose of investigational product and continuing through the end of the study. (approximately 4 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (4 terms)
| Reaction | System | Sorafenib |
|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Other, weakness | General disorders | — |
| Other, shortness of breath | Respiratory, thoracic and mediastinal disorders | — |
| Other, extremities tingling, numbness | General disorders | — |
Other adverse events (64 terms — click to expand)
| Reaction | System | Sorafenib |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Other, hand foot syndrome | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| Other, pain | General disorders | — |
| Fatigue | General disorders | — |
| Other- rash | Skin and subcutaneous tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Proteinuria | Renal and urinary disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Weight loss | Investigations | — |
| Gastroparesis | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Other, cramping | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Other, swelling | Vascular disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Insomnia | Psychiatric disorders | — |
| Other, upset stomach | Gastrointestinal disorders | — |
| Ejection fraction decreased | Investigations | — |
| Retinal detachment | Eye disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Other, mouth sensitivity | General disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Other, elevated cardiac enzymes | Cardiac disorders | — |
| Other, stomach cramps | Gastrointestinal disorders | — |
| Other, DVT | Vascular disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Other, increased alkaline phosphatase | Investigations | — |
| Other, blood in stool | Gastrointestinal disorders | — |
| Other, weak urine stream | Investigations | — |
| Other, pale face | Investigations | — |
| Other, Bleeding gums | Infections and infestations | — |
| Other, hematemesis | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Other, pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Pleural effusion, Other, weakness, Other, shortness of breath, Other, extremities tingling, numbness.
Data from ClinicalTrials.gov NCT00496756 adverse events section.
Sponsor's own description
RATIONALE: Sorafenib 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. PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Enhancing the clinical activity of sorafenib through dose escalation: rationale and current experience.
Semrad TJ, Gandara DR, Lara PN. · · 2011 · cited 10× · PMID 21789159 · DOI 10.1177/1758834010396117
Verify or expand the search:
- PubMed search for NCT00496756
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sorafenib
Trials testing the same drug.
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- NCT06474663 — A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabi · Phase 1 · withdrawn
- NCT06690697 — Combination of Toripalimab and JS004 Therapy for ccRCC · Phase 2 · recruiting
- NCT06177496 — Influence of Sarcopenia in Hepatocellular Carcinoma Patients · unknown
- NCT05033522 — Immunotherapy for Advanced Liver Cancer · Phase 2, PHASE3 · suspended
Other recruiting trials for Kidney Cancer
Currently open trials in the same condition.
- NCT07401875 — A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK) · Phase 1 · recruiting
- NCT07397611 — Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC · Phase 2 · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
- NCT06964958 — 177LuPSMA in Renal Cell Carcinoma · Phase 2 · active not recruiting
Other University of Nebraska trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00496756 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
- Last refreshed: 26 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00496756.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing