Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies

NCT00859118

Last updated date
Study Location
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53575, United States
Contact
1-800-718-1021

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have histologically or cytologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard therapy exists (although all solid malignancies will be enrolled, a subset will be designated for NSCL cancer will be given due to planned trials in this disease.

- must have measurable disease

- Must be greater than or equal to 18 years old.

- Life expectancy of greater than 12 weeks.

- ECOG performance status less than or equal to 2.

- Patients must have normal organ and marrow function

- Must be willing to undergo planned pharmacodynamic assessments, including serial PET imaging, plasma markers, and pharmacokinetic sampling.

- Women of childbearing potential and men must use adequate form of birth (hormonal or barrier method of birth control

- must have ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Must not havehad chemotherapy, radiotherapy, experimental therapy or major surgery
within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
or those who have not recovered (to grade less than or equal to 1 or baseline) from
clinically significant adverse events due to agents administered more than 4 weeks
earlier (alopecia and fatigue excluded).


- Patients may not be receiving any other investigational agents.


- Prior anti-VEGF directed therapy may be allowed only if approved by the PI


- Must not have history of allergic reactions attributed to compounds of similar
chemical or biologic composition to axitinib.


- Must not have poorly controlled hypertension (systolic blood pressure of 140 mmHg
or higher or diastolic blood pressure of 90 mmHg or higher)


- Must not require use of therapeutic doses of coumarin-derivative anticoagulants such
as warfarin, although doses of up to 2 mg daily are permitted for prophylaxis of
thrombosis.


- Patients with any condition (e.g., gastrointestinal tract disease resulting in an
inability to take oral medication or a requirement for IV alimentation, prior
surgical procedures affecting absorption, or active peptic ulcer disease) that
impairs their ability to swallow and retain axitinib tablets are excluded.


- Patients with any of the following conditions are excluded:


- Serious or non-healing wound, ulcer, or bone fracture.


- History of abdominal fistula, gastrointestinal perforation, or
intra-abdominal abscess within 28 days of treatment.


- Any history of cerebrovascular accident (CVA) or transient ischemic attack
within 12 months prior to study entry.


- History of myocardial infarction, cardiac arrhythmia, stable/unstable
angina, symptomatic congestive heart failure, or coronary/peripheral artery
bypass graft or stenting within 12 months prior to study entry.


- History of pulmonary embolism within the past 12 months.


- Class III or IV heart failure as defined by the NYHA functional
classification system.


- Patients without appropriate lesion on CT scan for FLT-PET/CT imaging will be
excluded.


- The eligibility of patients taking medications that are potent inducers or
inhibitors of that enzyme will be determined following a review of their case by
the Principal Investigator.


- Steroid use is not recommended during axitinib treatment unless absolutely
necessary


- Patients with a pre-existing thyroid abnormality who are unable to maintain
thyroid function in the normal range with medication are ineligible. Patients
with a history of hypothyroidism are eligible provided they are currently
euthyroid.


- Must not have known brain metastases are excluded.


- Must not have uncontrolled intercurrent illness including, but not limited to,
ongoing or active infections or psychiatric illness/social situations that would
limit compliance with study requirements


- Must not be pregnant or breastfeeding.


- Must not be HIV-positive on combination antiretroviral therapy

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies
Official Title  ICMJE Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies
Brief Summary

The main purpose of this study is to see what changes happen to the tumors while taking the axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor may be responsible for this growth. This will be done by using a special kind of scan called an 18F-FLT PET/CT.

In addition, the investigators want to find out how the drugs are processed and distributed in the human body. The investigators will also look at how different types of cancer are affected by axitinib. The investigators will also correlate vasculature kinetics extracted from the dynamic FLT PET/CT imaging with the vasculature kinetics extracted from DCE-CT.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: AG-013736
    Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only)
    Other Name: Axitinib
  • Drug: AG-013736
    Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only). After Scan#3 obtained, patients will commence with Axitinib 5 mg PO BID continuously without breaks, repeated in 3 week cycles.
    Other Name: Axitinib
Study Arms  ICMJE
  • Experimental: Schedule A Cohort 1

    Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only). After Scan#3 obtained, patients will commence with Axitinib 5 mg PO BID continuously without breaks, repeated in 3 week cycles.

    Scan#1: Baseline (days -3 to 0) Scan#2: Week 2 (between days 12-14) Scan#3: Week 3 (7 days after axitinib held) Up to 10 patients will receive 2 DCE-CT scans at week 2 and 3, coinciding with the FLT-PET scans.

    Intervention: Drug: AG-013736
  • Experimental: Schedule A: Cohort 2

    Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only). After Scan#3 obtained, patients will commence with Axitinib 5 mg PO BID continuously without breaks, repeated in 3 week cycles.

    Scan#1: Week 2 (between days 12-14) Scan#2: Week 3 (2 days after axitinib held) Scan#3: Week 3 (7 days after axitinib held) Up to 10 patients will receive 2 DCE-CT scans at week 2 and 3, coinciding with the FLT-PET scans.

    Intervention: Drug: AG-013736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have histologically or cytologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard therapy exists (although all solid malignancies will be enrolled, a subset will be designated for NSCL cancer will be given due to planned trials in this disease.

    • must have measurable disease
    • Must be greater than or equal to 18 years old.
    • Life expectancy of greater than 12 weeks.
    • ECOG performance status less than or equal to 2.
    • Patients must have normal organ and marrow function
    • Must be willing to undergo planned pharmacodynamic assessments, including serial PET imaging, plasma markers, and pharmacokinetic sampling.
    • Women of childbearing potential and men must use adequate form of birth (hormonal or barrier method of birth control
    • must have ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Must not havehad chemotherapy, radiotherapy, experimental therapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered (to grade less than or equal to 1 or baseline) from clinically significant adverse events due to agents administered more than 4 weeks earlier (alopecia and fatigue excluded).

    • Patients may not be receiving any other investigational agents.
    • Prior anti-VEGF directed therapy may be allowed only if approved by the PI
    • Must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to axitinib.
    • Must not have poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
  • Must not require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis.

    • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain axitinib tablets are excluded.
    • Patients with any of the following conditions are excluded:

      • Serious or non-healing wound, ulcer, or bone fracture.
      • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
      • Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry.
      • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
      • History of pulmonary embolism within the past 12 months.
      • Class III or IV heart failure as defined by the NYHA functional classification system.
    • Patients without appropriate lesion on CT scan for FLT-PET/CT imaging will be excluded.
    • The eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the Principal Investigator.
    • Steroid use is not recommended during axitinib treatment unless absolutely necessary
    • Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible. Patients with a history of hypothyroidism are eligible provided they are currently euthyroid.
    • Must not have known brain metastases are excluded.
    • Must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
    • Must not be pregnant or breastfeeding.
    • Must not be HIV-positive on combination antiretroviral therapy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859118
Other Study ID Numbers  ICMJE CO 08905
H-2008-0202 ( Other Identifier: Institutional Review Board )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
NCI-2011-00744 ( Registry Identifier: NCI Trial ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Glenn Liu, M.D.University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP