Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
NCT00940498
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Clinically unstable primary or metastatic CNS tumors
- Subjects with known diabetes
- QTc interval greater than 470 ms.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors | |||
| Official Title ICMJE | A Phase 1 Study Of Pf-05212384 (Also Known As Pki-587) Administered As An Intravenous Infusion To Patients With Solid Tumors | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Neoplasms | |||
| Intervention ICMJE | Drug: PF-05212384 (also known as PKI-587)
Intravenous dosing once weekly infusion | |||
| Study Arms ICMJE | Experimental: 1
PF-05212384 (also known as PKI-587) Intervention: Drug: PF-05212384 (also known as PKI-587) | |||
| Publications * | Shapiro GI, Bell-McGuinn KM, Molina JR, Bendell J, Spicer J, Kwak EL, Pandya SS, Millham R, Borzillo G, Pierce KJ, Han L, Houk BE, Gallo JD, Alsina M, Braña I, Tabernero J. First-in-Human Study of PF-05212384 (PKI-587), a Small-Molecule, Intravenous, Dual Inhibitor of PI3K and mTOR in Patients with Advanced Cancer. Clin Cancer Res. 2015 Apr 15;21(8):1888-95. doi: 10.1158/1078-0432.CCR-14-1306. Epub 2015 Feb 4. | |||
* 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 | Completed | |||
| Actual Enrollment ICMJE | 78 | |||
| Original Estimated Enrollment ICMJE | 80 | |||
| Actual Study Completion Date ICMJE | October 2012 | |||
| Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 99 Years (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 | Spain, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00940498 | |||
| Other Study ID Numbers ICMJE | B2151001 3265K1-1002 ( Other Identifier: Alias Study Number ) 2009-012379-85 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||