Clinical trial NCT00282048: Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Official title: Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Neoplasms
Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).


Eligibility criteria: Inclusion Criteria:

* RCC with metastases and nephrectomy
* failure of prior sorafenib-based therapy
* at least 1 target lesion that has not been irradiated
* adequate bone marrow, hepatic and renal function, \> or equal to 18 years of age.

Exclusion Criteria:

* Gastrointestinal abnormalities
* current use or inability to avoid chronic antacid therapy
* current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
* active seizure disorder or evidence of brain metastases.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks
measure: Duration of Response (DR)
timeFrame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least 1 year after the first dose for the last participant
measure: Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score
timeFrame: Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
measure: Population Pharmacokinetics of Axitinib (AG-013736)
timeFrame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Other outcomes:
measure: Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) Score
timeFrame: Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
measure: Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)
timeFrame: Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
measure: Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)
timeFrame: Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
measure: Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)
timeFrame: Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Locations:
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: