Trial Outcomes & Findings for Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer (NCT NCT00496756)

Last Updated: 2023-10-26

Results Overview

To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Study completion

Results posted on

2023-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib n=14 Participants sorafenib tosylate: initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg flow cytometry: 15 ml of blood drawn for flow cytometry of T4/T8, NK, CD25+, and Fox p3 testing obtained at baseline and on days 28, 56, 84, and 112 laboratory biomarker analysis: 15 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained at baseline.10 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained on days 28, 56, 84 and 112
Age, Customized Patients greater than or equal to 19 years of age	14 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Study completion

Population: Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from the start of the treatment until disease progression/recurrence

Population: Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.

The proportion of subjects with an objective response of complete or partial based on the RECIST Criteria

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib

Serious events: 2 serious events

Other events: 11 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib n=14 participants at risk The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • 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)
General disorders Other, weakness	7.1% 1/14 • Number of events 1 • 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)
Respiratory, thoracic and mediastinal disorders Other, shortness of breath	7.1% 1/14 • Number of events 1 • 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)
General disorders Other, extremities tingling, numbness	7.1% 1/14 • Number of events 1 • 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)

Other adverse events

Other adverse events
Measure	Sorafenib n=14 participants at risk The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.
Skin and subcutaneous tissue disorders Other- rash	28.6% 4/14 • Number of events 7 • 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)
General disorders Other, pain	35.7% 5/14 • Number of events 8 • 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)
Skin and subcutaneous tissue disorders Other, hand foot syndrome	50.0% 7/14 • Number of events 7 • 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)
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • 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)
Vascular disorders Hypertension	42.9% 6/14 • Number of events 6 • 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)
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Diarrhea	57.1% 8/14 • Number of events 10 • 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)
Skin and subcutaneous tissue disorders Alopecia	28.6% 4/14 • Number of events 4 • 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)
Gastrointestinal disorders Other, upset stomach	7.1% 1/14 • Number of events 2 • 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)
Investigations Ejection fraction decreased	7.1% 1/14 • Number of events 1 • 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)
General disorders Fatigue	35.7% 5/14 • Number of events 9 • 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)
Eye disorders Retinal detachment	7.1% 1/14 • Number of events 1 • 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)
Investigations Weight loss	14.3% 2/14 • Number of events 2 • 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)
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Nausea	28.6% 4/14 • Number of events 4 • 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)
Gastrointestinal disorders Vomiting	21.4% 3/14 • Number of events 3 • 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)
Gastrointestinal disorders Gastroparesis	14.3% 2/14 • Number of events 2 • 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)
General disorders Other, mouth sensitivity	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Dry skin	7.1% 1/14 • Number of events 1 • 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)
Renal and urinary disorders Proteinuria	21.4% 3/14 • Number of events 3 • 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)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • 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)
Blood and lymphatic system disorders Anemia	21.4% 3/14 • Number of events 3 • 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)
Cardiac disorders Other, elevated cardiac enzymes	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Other, stomach cramps	7.1% 1/14 • Number of events 1 • 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)
Nervous system disorders Headache	14.3% 2/14 • Number of events 3 • 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)
General disorders Other, cramping	14.3% 2/14 • Number of events 3 • 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)
Vascular disorders Other, DVT	7.1% 1/14 • Number of events 1 • 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)
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • 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)
Investigations Other, increased alkaline phosphatase	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Other, blood in stool	7.1% 1/14 • Number of events 1 • 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)
Investigations Other, weak urine stream	7.1% 1/14 • Number of events 1 • 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)
Investigations Other, pale face	7.1% 1/14 • Number of events 1 • 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)
Infections and infestations Other, Bleeding gums	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Other, hematemesis	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Hyperglycemia	14.3% 2/14 • Number of events 2 • 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)
Investigations Aspartate aminotransferase increased	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Hyperkalemia	7.1% 1/14 • Number of events 1 • 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)
Respiratory, thoracic and mediastinal disorders Other, pneumonitis	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Other, soreness mouth and throat	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, Blisters	7.1% 1/14 • Number of events 2 • 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)
Vascular disorders Other, pulmonary embolus	7.1% 1/14 • Number of events 1 • 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)
Renal and urinary disorders Other, renal insufficiency	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, tingling hands	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, lesions	7.1% 1/14 • Number of events 1 • 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)
Vascular disorders Other, swelling	14.3% 2/14 • Number of events 2 • 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)
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • 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)
General disorders Other, Weakness	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, cracking, erythema fingertips	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Ileus	7.1% 1/14 • Number of events 1 • 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)
Gastrointestinal disorders Other, Hematochezia	7.1% 1/14 • Number of events 1 • 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)
Musculoskeletal and connective tissue disorders Other, Soreness	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, Tenderness/burning scalp	7.1% 1/14 • Number of events 1 • 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)
Nervous system disorders Other, Neuropathy	7.1% 1/14 • Number of events 1 • 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)
Blood and lymphatic system disorders Other, Thrombocytopenia	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Other, Stomatitis	7.1% 1/14 • Number of events 1 • 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)
Renal and urinary disorders Hematuria (trace)	7.1% 1/14 • Number of events 1 • 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)
Investigations Other, decreased ionized calcium level	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Anorexia	7.1% 1/14 • Number of events 1 • 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)
Investigations Other, decreased magnesium level	7.1% 1/14 • Number of events 1 • 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)
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • 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)
Infections and infestations Other, Leukoplakia	7.1% 1/14 • Number of events 1 • 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)

Additional Information

Ralph Hauke, MD

University of Nebraska Medical Center

Phone: 402-354-8124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place