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Completed

NCT Number: NCT00726752

A Study In Patients With Advanced Solid Tumor

This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Kobe, Hyōgo, 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 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.

Treatment and study plan

Axitinib (AG-013736)

Drug

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.

Primary outcomes

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

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose

  2. 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).

  3. 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

  4. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2008
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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