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Completed

NCT Number: NCT00447005

Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.

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Key information

Conditions

Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients histologically or cytologically diagnosed with advanced malignant solid tumors
  • Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies

Exclusion criteria

  • Central lung lesions involving major blood vessels
  • Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)

Treatment and study plan

Axitinib (AG-013736)

Drug

AG-013736 5mg twice daily [BID]

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to 795 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 Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax): Single Dose

    Time frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose

    Time frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose

  3. Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose

    Time frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose

    AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).

  4. Terminal Phase Plasma Half-Life (t1/2): Single Dose

    Time frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose

    t1/2 is the time measured for the plasma concentration to decrease by one half.

  5. Maximum Observed Plasma Concentration (Cmax): Multiple Dose

    Time frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose

    Time frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose

  7. Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose

    Time frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose

    Dosing Interval was 12 hours in this study.

  8. Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose

    Time frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours 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)

  9. Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (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), Day 1 of Cycle 2 and at the discontinuation

    Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.

  10. The Numbers 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 795 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 13, 2007
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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