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A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Malignant Solid Tumors

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Trial Information

A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer


European Union: European Medicines Agency

Study ID:




Start Date:

February 2010

Completion Date:

February 2012

Related Keywords:

  • Advanced Malignant Solid Tumors
  • Phase 1
  • Maximum tolerated dose
  • Solid tumors
  • Neoplasms