|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
NCT00878189 |
|
Date of registration:
|
06/04/2009 |
|
Primary sponsor: |
|
|
Public title:
|
A Trial In Patients With Advanced Cancer And Leukemia
|
|
Scientific title:
|
A Phase 1 Trial Of PF-03084014 In Patients With Advanced Solid Tumor Malignancy And T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma |
|
Date of first enrolment:
|
June 2009 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00878189 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Italy
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with advanced cancer that is resistant to standard therapy or for which no
standard therapy is available
- Patients with acute T cell leukemia/lymphoblastic lymphoma that is resistant to
standard therapy or for which no standard therapy is available
- Men and women >16 years old
Exclusion Criteria:
- Prior treatment with a gamma secretase inhibitor for treatment of cancer
- Patients taking Tamoxifen
- Patients with active graft versus host disease
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness
- Patients who are pregnant or breast feeding
- Patients with clinical evidence of central nervous system disease
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Leukemia, Lymphoid
|
|
Leukemia, T-Cell
|
|
Neoplasms by Histologic Type
|
|
Solid Tumors
|
|
Intervention(s)
|
|
Drug: PF-03084014
|
|
Primary Outcome(s)
|
|
Number of participants with Dose-limiting toxicities (DLT)
[Time Frame: 28 days]
|
|
Overall safety profile characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities.
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
Changes in NICD levels and expression levels of Notch1 target genes
[Time Frame: 28 days]
|
|
Concentrations of PF 03084014 and dexamethasone at selected timepoints
[Time Frame: 2 years]
|
|
Objective tumor response, overall response rate, time to tumor progression, progression free survival, and duration of response
[Time Frame: 2 years]
|
|
QTc interval
[Time Frame: 2 years]
|
|
Serum pharmacokinetic parameters of PF-03084014
[Time Frame: 2 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|