Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00076011
• Date of registration: 12/01/2004
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
• Scientific title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer
• Date of first enrolment: October 2003
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00076011
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France, Germany, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically documented RCC with metastases.

- Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to
disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

- Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior
cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an
anti-angiogenesis agent are not allowed.

- Inability to take oral medication



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Neoplasms

Intervention(s)

Drug: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor

Primary Outcome(s)

Percentage of Participants With Objective Response (OR) [Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks]

Secondary Outcome(s)

Overall Survival (OS) [Time Frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant]

Duration of Response (DR) [Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks]

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score [Time Frame: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose]

Time to Disease Progression (TTP) [Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks]

Secondary ID(s)

A4061012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00076011