Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 11/4/2018 |
| Start Date: | January 2010 |
| End Date: | October 2012 |
A Phase 1 Study Of Pf-05212384 (Also Known As Pki-587) Administered As An Intravenous Infusion To Patients With Solid Tumors
This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The
purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a
Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In
Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and
preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,
ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of
brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who
consent to provide tumor biopsies while participating in the study.
purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a
Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In
Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and
preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,
ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of
brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who
consent to provide tumor biopsies while participating in the study.
Inclusion Criteria:
- Pathologic diagnosis of any solid tumor
- Incurable cancer, with disease progression following at least 1 therapy with no
further standard treatment available in the opinion of the investigator.
- At least 1 evaluable lesion per RECIST criteria
Exclusion Criteria:
- Clinically unstable primary or metastatic CNS tumors
- Subjects with known diabetes
- QTc interval greater than 470 ms.
We found this trial at
7
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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