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Study of PKI-179 Administered Orally to Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00997360
Recruitment Status : Withdrawn
First Posted : October 19, 2009
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date September 27, 2018
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
Safety as measured by physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00997360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
Tumor assessments, blood samples to look at how the drug enters your body and what the body does with it. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Official Title  ICMJE A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Brief Summary This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
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 Advanced Malignant Solid Tumors
Intervention  ICMJE Drug: PKI-179
Study Arms  ICMJE Experimental: 1
PKI-179
Intervention: Drug: PKI-179
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2009)
80
Estimated Study Completion Date  ICMJE February 2012
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects age 18 years or older.
  2. Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor. Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.
  3. Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides for exploratory biomarker analysis.
  4. Incurable cancer, with disease progression following at least 1 conventional, standard, or investigational therapy with no further standard treatment available in the opinion of the investigator.
  5. At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  6. Eastern Cooperative Oncology Group (ECOG) 0 to 2.
  7. Acceptable laboratory values, including fasting serum glucose.
  8. All male and female subjects who are biologically capable of having children, must agree to use a medically acceptable method of birth control for the duration of the study (e.g., condom with a spermicide) and for 12 weeks after the last dose of investigational product. All female subjects who are biologically capable of having children must have a negative serum pregnancy test result before first dose of investigational product. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the active treatment phase of the study or for 12 weeks after the last dose of investigational product.

Exclusion criteria:

  1. Major surgery, chemotherapy, radiotherapy, investigational therapy, or other cancer therapy within 2 weeks prior to first dose of investigational product.
  2. Lack of recovery from any prior surgery, chemotherapy, radiotherapy, or other cancer therapy.
  3. Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks before first dose of PKI-179 (no significant change in anticonvulsant doses, mental status, or clinical symptoms related to the CNS tumors).
  4. Subjects with known diabetes.
  5. QTc interval > 470 ms.
  6. Pregnant or breastfeeding women.
  7. Evidence of significant medical illness or abnormal laboratory finding that in the opinion of the investigator would substantially increase the risk associated with the subject's participation in the study or impact the assessment of safety and/or efficacy. Examples include, but are not limited to: uncontrolled seizures, serious ongoing active infection requiring treatment, significant uncontrolled cardiac disease, such as congestive heart failure, myocardial infarction within past 6 months, angina requiring treatment, or other clinically significant or uncontrolled conditions.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997360
Other Study ID Numbers  ICMJE 3266A1-1002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2018

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