A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients

NCT00927823

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90095-6984, United States
Contact
1-800-718-1021

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]

Call Now

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

- Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of the first dose of PF-04961502, These patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate

- Adequate Bone Marrow Function, including:

1. Absolute neutrophil count (ANC) ≥1500 cells/mm3

2. Platelets ≥75,000 cells/mm3

3. Hemoglobin ≥9 mg/dL

- Adequate Renal Function, including:

SrCr <1.5 x ULN (upper limit of normal). OR Estimated creatinine clearance ≥60 mL/min, as calculated using method standard for the institution

- Adequate Liver Function, including:

Bilirubin ≤1.5 x ULN AST (SGOT) ≤2.5 x ULN ALT (SGPT) ≤2.5 x ULN

- Adequate glucose control, including no previous diagnosis of diabetes mellitus and HbA1c <7%.

- Adequate Cardiac Function, including:

12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention. QTc interval ≤470 msec and no history of Torsades des Pointes or other symptomatic QTc abnormality

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


- Patients with known active brain metastases. Patients with previously diagnosed brain
metastases are eligible if they have completed their CNS treatment and have recovered
from the acute effects of radiation therapy or surgery prior to the start of study
medication, have discontinued corticosteroid treatment for these metastases for at
least 4 weeks and are neurologically stable


- Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will
not be followed for tumor assessment on this study, ie, non target lesions),
biological or investigational agents within 2 weeks of Baseline disease assessments


- Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks
of Baseline disease assessments; or not fully recovered from any side effects of
previous procedures


- Prior therapy with an agent that is known or proposed to be active by action on PI3K
and/or mTOR


- Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within
12 months of study treatment start


- Uncontrolled or significant cardiovascular disease:


A myocardial infarction within 12 months Uncontrolled angina within 6 months Congestive
heart failure within 6 months. Diagnosed or suspected congenital long QT syndrome. Any
history of ventricular arrhythmias (such as ventricular tachycardia, ventricular
fibrillation, or Torsades de pointes). Any history of second or third degree heart block
(may be eligible if currently have a pacemaker) Heart rate <50/minute on pre-entry
electrocardiogram Uncontrolled hypertension.


- Current use or anticipated need for food or drugs that are known potent CYP3A4
inhibitors or inducers


- Current use or anticipated need for food or drugs that are known potent CYP1A2
inhibitors or inducers


- Concurrent administration of herbal preparations


- Breast feeding: No studies have been conducted in humans to assess the impact of
PF-04691502 on milk production, its presence in breast milk and its effects on the
breast-fed child. Because drugs are commonly excreted in human milk and because of the
potential for serious adverse reactions in nursing infants, lactating female patients
are excluded from this study.


- Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drug, such as the inability to take oral medication
in tablet form and malabsorption syndrome.


- Any mental disorder that would limit the understanding or rendering of informed
consent and/or compromise compliance with the requirements of this protocol

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

CancerA Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients NCT00927823
  1. Los Angeles, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Santa Monica, California
  5. Detroit, Michigan
  6. Amherst, New York
  7. Buffalo, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
CancerEvaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer NCT00942968
  1. Tuscon, Arizona
  2. Pleasant Hill, California
  3. Torrance, California
  4. Farmington, Connecticut
  5. Norwich, Connecticut
  6. Washington, District of Columbia
  7. Daytona Beach, Florida
  8. Decatur, Georgia
  9. Skokie, Illinois
  10. Louisville, Kentucky
  11. Boston, Massachusetts
  12. Detroit, Michigan
  13. Rochester, New York
  14. Stony Brook, New York
  15. Durham, North Carolina
  16. Bismarck, North Dakota
  17. Philadelphia, Pennsylvania
  18. Houston, Texas
  19. Salt Lake City, Utah
  20. Burlington, Vermont
  21. Charlottesville, Virginia
  22. Graz,
  23. Innsbruck,
  24. Linz,
  25. Linz,
  26. St. Poelten,
  27. Vienna,
  28. Edmonton, Alberta
  29. Vancouver, British Columbia
  30. Halifax, Nova Scotia
  31. London, Ontario
  32. Ottawa, Ontario
  33. Toronto, Ontario
  34. Montreal, Quebec
  35. Montreal, Quebec
  36. Apeldoorn,
  37. Sittard-Geleen,
  38. Barcelona,
  39. Caragena (Murcia),
  40. El Palmar (Murcia),
  41. Girona,
  42. Pamplona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
CancerOpen-Label Extension and Safety Study of Talazoparib NCT02921919
  1. Atlanta, Georgia
  2. Atlanta, Georgia
  3. Atlanta, Georgia
  4. Atlanta, Georgia
  5. Alhambra, California
  6. Bakersfield, California
  7. Burbank, California
  8. Fullerton, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Los Angeles, California
  15. Los Angeles, California
  16. Pasadena, California
  17. Porter Ranch, California
  18. Santa Monica, California
  19. Torrance, California
  20. Valencia, California
  21. Orlando, Florida
  22. Pembroke Pines, Florida
  23. Bloomington, Indiana
  24. Fort Wayne, Indiana
  25. Fort Wayne, Indiana
  26. Indianapolis, Indiana
  27. Indianapolis, Indiana
  28. Indianapolis, Indiana
  29. Boston, Massachusetts
  30. Boston, Massachusetts
  31. Ann Arbor, Michigan
  32. Detroit, Michigan
  33. New Brunswick, New Jersey
  34. Houston, Texas
  35. Edmonton, Alberta
  36. Hamilton, Ontario
  37. Montreal, Quebec
  38. Marseille cedex 09,
  39. Erlangen,
  40. Budapest,
  41. Budapest,
  42. Chisinau,
  43. Warszawa,
  44. Moscow,
  45. Saint-Petersburg,
  46. Sutton, Surrey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
Official Title  ICMJE A Phase 1, Open-Label, Dose-Escalation Study To Evaluate Safety, Pharmacokinetics, And Pharmacodynamics Of The PI3K/MTOR Inhibitor PF-04691502 In Adult Patients With Advanced Malignant Solid Tumors
Brief Summary A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.
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 Cancer
Intervention  ICMJE Drug: PF-04691502
Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation.
Study Arms  ICMJE Experimental: PF-04691502 Treatment
Intervention: Drug: PF-04691502
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: May 29, 2012)
37
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2009)
75
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of the first dose of PF-04961502, These patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate
  • Adequate Bone Marrow Function, including:

    1. Absolute neutrophil count (ANC) ?1500 cells/mm3
    2. Platelets ?75,000 cells/mm3
    3. Hemoglobin ?9 mg/dL
  • Adequate Renal Function, including:

SrCr <1.5 x ULN (upper limit of normal). OR Estimated creatinine clearance ?60 mL/min, as calculated using method standard for the institution

  • Adequate Liver Function, including:

Bilirubin ?1.5 x ULN AST (SGOT) ?2.5 x ULN ALT (SGPT) ?2.5 x ULN

  • Adequate glucose control, including no previous diagnosis of diabetes mellitus and HbA1c <7%.
  • Adequate Cardiac Function, including:

    12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention. QTc interval ?470 msec and no history of Torsades des Pointes or other symptomatic QTc abnormality

Exclusion Criteria:

  • Patients with known active brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable
  • Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 2 weeks of Baseline disease assessments
  • Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks of Baseline disease assessments; or not fully recovered from any side effects of previous procedures
  • Prior therapy with an agent that is known or proposed to be active by action on PI3K and/or mTOR
  • Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within 12 months of study treatment start
  • Uncontrolled or significant cardiovascular disease:

A myocardial infarction within 12 months Uncontrolled angina within 6 months Congestive heart failure within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Any history of second or third degree heart block (may be eligible if currently have a pacemaker) Heart rate <50/minute on pre-entry electrocardiogram Uncontrolled hypertension.

  • Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors or inducers
  • Current use or anticipated need for food or drugs that are known potent CYP1A2 inhibitors or inducers
  • Concurrent administration of herbal preparations
  • Breast feeding: No studies have been conducted in humans to assess the impact of PF-04691502 on milk production, its presence in breast milk and its effects on the breast-fed child. Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, lactating female patients are excluded from this study.
  • Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form and malabsorption syndrome.
  • Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol
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 NCT00927823
Other Study ID Numbers  ICMJE B1271001
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014

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