A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

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NCT01105533

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Study Location
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]izer.com

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm
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

- Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.

- At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].

- Adequate bone marrow, liver function and renal function as defined by protocol.

- Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.

During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

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


- Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study
entry


- Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.


- Patients with carcinomatous meningitis or un-treated brain metastases.


- Any acute cardiovascular incident within the past 12 months.


- Patients with active gastrointestinal bleeding or significant gastrointestinal
abnormalities as defined by protocol


- Patients with no evidence of the following for 5 years: malignancy or metastatic
disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or
T1C prostate cancer.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
Official Title  ICMJE Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors
Brief Summary This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm
Intervention  ICMJE
  • Drug: PF-00337210
    0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous
  • Drug: PF-00337210
    1mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    2mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    4mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    6mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    9mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    8mg Capsule Once Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    4mg Capsule Twice Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    6mg Capsule Twice Daily (Dose Escalation) Continuous
  • Drug: PF-00337210
    6mg Capsule Twice Daily (Dose Expansion) Continuous
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 2
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 3
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 4
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 5
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 6
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 7
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 8
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 9
    Intervention: Drug: PF-00337210
  • Experimental: Cohort 10
    Intervention: Drug: PF-00337210
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: April 15, 2010)		46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
  • At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].
  • Adequate bone marrow, liver function and renal function as defined by protocol.
  • Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.

During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

Exclusion Criteria:

  • Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
  • Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
  • Patients with carcinomatous meningitis or un-treated brain metastases.
  • Any acute cardiovascular incident within the past 12 months.
  • Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
  • Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.
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 NCT01105533
Other Study ID Numbers  ICMJE A8051001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE University of Wisconsin, Madison
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

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