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

Last updated on May 9, 2018

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

NCT01105533
Pfizer
Completed
A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

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Pfizer Clinical Trials Contact Center

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A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasm
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
September 2011
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01105533
A8051001
No
Not Provided
Not Provided
Pfizer
Pfizer
University of Wisconsin, Madison
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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