An Open-Label, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics fo the PARP Inhibitor AZD2461 in Patients With Refractory Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Refractory Solid Tumors, Cancer Tumor
Both
Refractory Solid Tumors, Cancer Tumor
Trial Information
An Open-Label, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics fo the PARP Inhibitor AZD2461 in Patients With Refractory Solid Tumors
Inclusion Criteria:
- Patients with confirmed diagnosis of solid tumor malignancy that is not responsive to
standard therapies or for which there is no effective therapy.
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
- Patients must be 18 years of age
- Using adequate contraceptive measures, be surgically sterile or post-menopausal
- Patients entering this study must be willing to provide tissue from a previous tumor
biopsy (if available) for correlative testing. If tissue is not available, a patient
will still be eligible for enrollment into the study..
Exclusion Criteria:
- Patients currently receiving cancer therapy
- Use of investigation anti-cancer drug or major surgery, radiotherapy or immunotherapy
with the last 21 days
- cardiac disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs.
Outcome Time Frame:
Day 1
Safety Issue:
Yes
Principal Investigator
Andrew Hughes, MA, MB, ChB, PhD, P
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D3660C00001
NCT ID:
NCT01247168
Start Date:
November 2010
Completion Date:
May 2011
Related Keywords:
- Refractory Solid Tumors
- Cancer Tumor
- Refractory
- Solid tumors
- Cancer
- Neoplasms
Name | Location |
|---|---|
| Research Site | Chattanooga, Tennessee |
