Overview

This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatments axitinib
Phase phase 2
Targets VEGF, PDGF
Sponsor Pfizer
Start date August 2009
End date October 2012
Trial size 213 participants
Trial identifier NCT00835978, A4061046

Summary

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
Randomized arm
axitinib
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
(Other)
Randomized arm
axitinib
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
(Other)
Non-randomized arm
axitinib
axitinib 5mg BID (open-label)

Primary Outcomes

Measure
Objective Response Rate (ORR) - Percentage of Participants With Objective Response
time frame: Baseline up to disease progression, death, or withdrawal with minimum follow-up of 12 months; assessments performed at baseline and repeated every 8 weeks.

Secondary Outcomes

Measure
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (All Participants)
time frame: Baseline up to disease progression, death, or withdrawal with minimum follow-up of 12 months; assessments performed at baseline and repeated every 8 weeks.
Progression-Free Survival (PFS)
time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
Progression-Free Survival (PFS) - All Participants
time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
Duration of Response (DR)
time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
Overall Survival (OS)
time frame: Baseline up to at least one year after the last patient has been randomized.
Maximum Observed Plasma Concentration (Cmax) of Axitinib
time frame: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Plasma Decay Half-Life (t1/2) for Axitinib
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Oral Clearance (CL/F) of Axitinib
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib
time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Change From Baseline in Systolic Blood Pressure
time frame: Baseline up to follow-up visit
Change From Baseline in Diastolic Blood Pressure
time frame: Baseline up to follow-up visit
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline
time frame: Baseline
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline
time frame: Cycle 1 Day 1 (C1D1), C1D15, C2D15, End of therapy (EOT)
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+
time frame: Baseline
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline
time frame: C1D1, C1D15, C2D15, EOT
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
time frame: Baseline, C1D1
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
time frame: Baseline, C1D1

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - metastatic renal cell carcinoma (kidney cancer) with clear cell component - no prior systemic therapy (including no prior adjuvant or neoadjuvant) - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - Blood Pressure < or = 140/90mmHg Exclusion Criteria: - brain/CNS metastasis - using more than 2 blood pressure medications

Additional Information

Official title Randomized, Double-Blind Phase 2 Study of Axitinib (AG-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pfizer.