Trial record 1 of 1 for:
A4061035
Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00569946 |
Recruitment Status :
Completed
First Posted : December 10, 2007
Results First Posted : March 27, 2012
Last Update Posted : June 5, 2019
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Renal Cell |
Intervention |
Drug: AG-013736 |
Enrollment | 64 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | AG-013736 |
---|---|
Arm/Group Description | The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced. |
Period Title: Overall Study | |
Started | 64 |
Completed | 5 |
Not Completed | 59 |
Reason Not Completed | |
Adverse Event | 16 |
Objective Progression or Relapse | 42 |
Global Deterioration of Health Status | 1 |
Baseline Characteristics
Arm/Group Title | AG-013736 | |
---|---|---|
Arm/Group Description | The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced. | |
Overall Number of Baseline Participants | 64 | |
Baseline Analysis Population Description |
[Not Specified]
|
|
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 64 participants | |
<18 |
0 0.0%
|
|
18-44 |
6 9.4%
|
|
45-64 |
30 46.9%
|
|
>= 65 |
28 43.8%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 64 participants | |
Female |
20 31.3%
|
|
Male |
44 68.8%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00569946 |
Other Study ID Numbers: |
A4061035 |
First Submitted: | December 7, 2007 |
First Posted: | December 10, 2007 |
Results First Submitted: | February 25, 2012 |
Results First Posted: | March 27, 2012 |
Last Update Posted: | June 5, 2019 |