Clinical Trials Logo
  1. Home
  2. Carcinoma, Renal Cell
  3. NCT01056263
  4. Details
NCT01056263 Clinical Trial

Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012

Carcinoma, Renal Cell Clinical Trial

Official title:
Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056263
Other study ID # A4061065
Secondary ID
Status Completed
Phase N/A
First received January 25, 2010
Last updated April 18, 2012
Start date April 2010
Est. completion date December 2010

Study information
Verified date April 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 [NCT00076011] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

Description:

Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919]. Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919].

5-year survival information to be updated.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects participating in this observational study originally participated in study A4061012 [NCT00076011] and may have also participated in study A4061008 [NCT00828919]

Exclusion Criteria:

- Subjects who withdrew from the original study A4061012 [NCT00076011] or the continuing access study A4061008 [NCT00828919]

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• axitinib: observational study
Non-interventional observational study

Locations
Country Name City State
France Pfizer Investigational Site Paris Cedex 13
Germany Pfizer Investigational Site Hannover
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact. Baseline until death or up to Year 5 No
See also
  Status Clinical Trial Phase
Completed NCT02248389 - Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses Phase 1
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT00158782 - Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients Phase 1
Completed NCT03109015 - Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing Phase 2
Completed NCT00363194 - A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients Phase 1
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Completed NCT00842790 - Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging N/A
Completed NCT00529802 - Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer Phase 2
Completed NCT00387764 - Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer Phase 3
Completed NCT00338884 - Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer Phase 2
Completed NCT00356460 - Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma Phase 1
Completed NCT00095186 - Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma Phase 2
Completed NCT00079612 - Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer Phase 2
Completed NCT00043368 - PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909) Phase 2
Active, not recruiting NCT04489771 - A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Phase 2
Completed NCT00516672 - Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors Phase 1
Withdrawn NCT05104905 - A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT03111901 - Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer Phase 1/Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1

External Links