A Study In Patients With Advanced Solid Tumor

• ClinicalTrials.gov Identifier: NCT00726752
• Recruitment Status: Completed
• First Posted: August 1, 2008
• Results First Posted: March 26, 2012
• Last Update Posted: May 23, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 30, 2008
• First Posted Date: August 1, 2008
• Results First Submitted Date: February 25, 2012
• Results First Posted Date: March 26, 2012
• Last Update Posted Date: May 23, 2012
• Study Start Date: July 2008
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2012)

• Single Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
• Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
  AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
• Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
• Single Dose: Plasma Decay Half-Life (t1/2) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

• Original Primary Outcome Measures (submitted: July 30, 2008): Plasma pharmacokinetics of AG-013736 following single dosing [ Time Frame: 1 year ]

Current Secondary Outcome Measures (submitted: May 17, 2012)

• Multiple Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
  Cmax at multiple dosing
• Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
  The dosing interval was 12 hours in this study.
• Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
  Tmax at multiple dosing
• Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
  Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)
• Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT ) [ Time Frame: Prior to the initial dose (baseline) and Day 1 of Cycle 2 ]
  Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF
• Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) [ Time Frame: Up to 470 days ]
  CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
• Number of Participants With Adverse Events [ Time Frame: Up to 470 days of treatment plus 28-days follow-up ]
  Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.

Original Secondary Outcome Measures (submitted: July 30, 2008)

• Adverse events [ Time Frame: End of study ]
• Plasma pharmacokinetics of AG-013736 following multiple dosing [ Time Frame: End of study ]
• Pharmacodynamic indices [ Time Frame: End of study ]
• Anti-tumor effect [ Time Frame: End of study ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study In Patients With Advanced Solid Tumor
• Official Title: A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
• Brief Summary: This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neoplasms

Intervention

Drug: Axitinib (AG-013736)

Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Study Arms

Experimental: Axitinib

Intervention: Drug: Axitinib (AG-013736)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 30, 2008): 6
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients histologically or cytologically diagnosed with advanced solid tumors
• Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
• Patients with no uncontrolled hypertension

Exclusion Criteria:

• Patients who have central lung lesions involving major blood vessels
• Patients who require anticoagulant therapy.
• Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00726752
• Other Study ID Numbers: A4061044
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2012