
Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00997360 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Wyeth is now a wholly owned subsidiary of Pfizer |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Monitor |
Principal Investigator Affiliation | Wyeth is now a wholly owned subsidiary of Pfizer |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Withdrawn |
Countries | |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Advanced Malignant Solid Tumors |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.