Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors (B2151001)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00940498
First received: July 14, 2009
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: PF-05212384 (also known as PKI-587) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Assessment of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess safety and tolerability at the MTD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Assess how the study drug enters the body and what the body does with it [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assess how well the study drug works [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assess the effect of the study drug on tumors and other tissues [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 78 |
| Study Start Date: | January 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
PF-05212384 (also known as PKI-587)
|
Drug: PF-05212384 (also known as PKI-587)
Intravenous dosing once weekly infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940498
Locations
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10065 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203-1632 | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| London, England, United Kingdom, SE1 9RT | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00940498 History of Changes |
| Other Study ID Numbers: | B2151001, 3265K1-1002 |
| Study First Received: | July 14, 2009 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 Dose Finding Solid Tumors Tumors PF-05212384 |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013