Trial Outcomes & Findings for Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract (NCT NCT00112671)

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2018-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sorafenib Tosylate) Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sorafenib Tosylate) n=17 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Age, Continuous	67 years n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment Canada	17 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=17 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Number of Paricipants With Tumour Response Defined as Partial or Complete Response Per the RECIST 1.0 Criteria	0 participants

SECONDARY outcome

Timeframe: From the start of the treatment until the criteria for progression are met, up to 5 years

Population: Stable disease for more than 3 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=17 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Number of Participants With Stable Disease for More Than 3 Months	1 participants

SECONDARY outcome

Timeframe: Up to 5 years

Progression is defined using the Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=17 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Time to Progression	1.9 months Interval 1.7 to 4.3

SECONDARY outcome

Timeframe: From start of treatment to progression or death, assessed up to 1 year

Population: 3 months progression free survival

Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Survival estimates will be computed using the Kaplan-Meier method. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=14 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Progression-free Survival	27 percentage of participants Interval 12.0 to 61.0

SECONDARY outcome

Timeframe: Up to 5 years

Will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=17 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
Frequency of Common Grade 3 Adverse Events	3 common grade 3 events

Adverse Events

Treatment (Sorafenib Tosylate)

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sorafenib Tosylate) n=17 participants at risk Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
General disorders Multi-organ failure	5.9% 1/17 • Number of events 1
General disorders Death NOS	5.9% 1/17 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Sorafenib Tosylate) n=17 participants at risk Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally laboratory biomarker analysis: Correlative studies
General disorders Fatigue	94.1% 16/17 • Number of events 16
Metabolism and nutrition disorders Anorexia	70.6% 12/17 • Number of events 12
Gastrointestinal disorders Constipation	64.7% 11/17 • Number of events 11
Gastrointestinal disorders Abdominal pain	23.5% 4/17 • Number of events 4
Musculoskeletal and connective tissue disorders back pain	23.5% 4/17 • Number of events 4
Skin and subcutaneous tissue disorders hand-foot reaction	17.6% 3/17 • Number of events 3
Infections and infestations bladder infection	17.6% 3/17 • Number of events 3

Additional Information

Dr. Srikala Sridhar

Princess Margaret Phase II Consortium

Phone: 416-946-4501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60