Study of PKI-179 Administered Orally to Subjects With Solid Tumors
NCT00997360
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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.
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.
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Descriptive Information | ||||
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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 | 0 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |